WELCOME TO THE 170 MEETING. THE MORNING SESSION OF THE MEETING IS OPEN TO THE PUBLIC AND BROADCAST ON THE NIH VIDEOCAST NETWORK. WE ARE DELIGHTED TO HAVE THE COUNCIL MEMBERS WITH US TODAY, INCLUDING SOME OLD AND SOME NEW. DOCTOR ATULE BOOUT AND RACHEL CRAIGMAN AND -- DR. VES ILLOSE PAP ADOP LIST AND THEY ARE JOINING US AS AD HOC REVIEWERS. AS A REMINDER ALL COUNCILS HAVE THE OPTION OF PARTICIPATING FOR ONE MEETING A YEAR. UNFORTUNATELY DR. SUZANNE BOOK HIEMER AND DR. TIM THINK SHRIVER WILL BE ENABLE TO MEET WITH US TODAY. MAKE SURE THAT THE TRANSCRIBER AND VIDEO CAST OBSERVERS WILL KNOW WHO IS SPEAKING. WE ARE HAPPY TO HAVE GUESTS WITH US TODAY FROM PROFESSIONAL SOCIETIES AND ADVOCACY ORGANIZATIONS. WE THANK YOU FOR BEING HERE. WE WOULD LIKE TO TAKE A MOMENT FOR EACH GUEST TO STANDIN TROD USE YOURSELF SO WE MAY WELCOME YOU. >> EVERYONE IS OFF MUTE SO MAKE SURE IF YOU ARE NOT SPEAKING TO MUTE YOUR PHONE. THANK YOU. p>> THANK YOU FOR BEING HERE AND FOR ALL THAT YOU DO AND YOUR ORGANIZATIONS DO TO SUPPORT THE NICHD AND ITS MISSION. NOW I WILL TURN THE MEETING OVER TO DR. DELLA HANN. >> GOOD MORNING, EVERYONE. ON THE COUNCILMEMBER WEBSITE YOU SHOULD HAVE READ AND AGREED TO AND SIGNED THE CONFIDENTIAL NONDISCLOSURE RULES. ALSO, AT YOUR SEAT, YOU WILL FIND A RED FOLDER. KARMEN HAS HERS RIGHT HERE. INSIDE OF THE FOLDER IS A CONFLICT OF INTEREST CERTIFICATION FORM. AS MANY OF YOU KNOW INFORMATION REGARDING YOUR CONFLICTS OF INTEREST IS APPLIED WHEN DISCUSSING APPLICATIONS AND ISSUES SPECIFIC TO PERTINENT ORGANIZATIONS. IF THERE IS A SPECIFIC DISCUSSION ON ANY ORGANIZATION OR UNIVERSITY FOR WHICH YOU ARE IN CONFLICT, IN ADDITION TO THE LISTED IN THE COUNCIL ACTION DOCUMENTS, YOU WILL BE REQUIRED TO RECUSE YOURSELF FROM THE DISCUSSION AND TO LEAVE THE ROOM. PLEASE SIGN THE ENCLOSED CONFLICT OF INTEREST CERTIFICATION FORM PRIOR TO THE AFTERNOON'S CLOSED SESSION FOR THE REVIEW OF APPLICATIONS. ALSO, REMEMBER THAT YOU CAN'T SERVE ON ANY NIHP REVIEW PANEL WHILE YOU SERVE AS A COUNCILMEMBER. SOME CONSIDER IT TO BE A BONUS. NIH POLICY THAT INDIVIDUAL CONDITION THE SERVE ON FIRST AND SECOND LEVEL OF PEER REVIEW. OKAY? WITH THAT, I WILL TURN NOW TO THE COUNCIL MINUTES FROM THE JANUARY MEETING WERE POSTED ON NICHD INTRANET AND COUNCIL MEMBER WEBSITES CAN I HAVE A MOTION WITH REGARD TO THE ACTION YOU WOULD LIKE TO TAKE REGARDING THE MINUTES? OKAY. MOVE AND SECOND. OKAY. GREAT. THOSE IN FAVOR OF AGREEING WITH THE MINUTES AS THEY ARE, PLEASE RAISE YOUR HAND. LOOKING ON THE CAMERA SCREEN, THERE WE GO. THANK YOU, DICK. I HEARD A TOOL. GREAT. OKAY. THOSE NOT IN FAVOR? ANY ABSTENTIONS? TERRIFIC. THANK YOU VERY MUCH. REMINDER THAT FUTURE MEETING DATES FOR THE COUNCIL HAVE ALSO BEEN POSTED WHICH ARE THIS FALL SEPTEMBER 18TH AND 19TH THAT WILL BE A TWO-DAY MEETING, JANUARY 23RD AND 2020 THAT HAPPENS TO BE THURSDAY. JUNE 11TH, 2020 WHICH IS A THURSDAY AND SEPTEMBER 10TH, 2020 WHICH IS ALSO A THURSDAY. I WILL NOW TURN THE MEETING BACK TO DR. BIANCHI TO DO THE DOCTOR'S REPORT AND DISCUSSION. THANK YOU. >> >> THAJS R R THAJS IT YOU IT IS MY PLEASURE TO DO THE DIRECTOR'S REPORT AND WE WILL DISCUSS THE FISCAL YEAR 2020 APPROPRIATIONS. THEN I WILL GIVE YOU UPDATES ON SELECTED NICHD INITIATIVES INCLUDING LATE-BREAKING INFORMATION FROM THE DOWN SYNDROME COMMUNITY AND NEWS ON INSTITUTE AND CENTER LEADERSHIP AT NIH AND IN A SUBSEQUENT PRESENTATION, WE WILL GET TO STRATEGIC PLANNING. BACK IN APRIL, I TESTIFIED AT THE FISCAL YEAR 2020 HOUSE APPROPRIATIONS HEARING WITH DR. COLLINS, FOUCHI, LIBY, AND VOLCOUGH. WHAT WAS INTERESTING TO ME IS 9 OF THE 13 MEMBERS OF THE COMMITTEE ARE NOW WOMEN. CONSEQUENTLY, THERE WERE LOTS MORE QUESTIONS RELATED TO AREAS IN WHICH NICHD HAS A SCIENTIFIC INTEREST. I FIELDED QUESTIONS ABOUT MATERNAL MORTALITY AND WHAT IS HAPPENING WITH OUR TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND LACTATING WOMEN AND THEY ASKED QUESTIONS ABOUT NEWBORN SCREENING AND POSTPARTUM DEPRESSION AND PEDIATRIC RESEARCH AND WHAT IS HAPPENING WITH PEDIATRIC RESEARCH. I WANT EVERYBODY IF IN THE ROOM AS WELL AS EVERYBODY LISTENING OUT THERE IN CYBER SPACE TO KNOW THERE IS STRONG BIPARTISAN SUPPORT EXPRESSED FOR NIH FUNDING. THIS IS GENUINE THAT WE HEAR NOT ONLY IN THE TELEVISED HEARINGS. WE HEAR IT IN MANY EVENTS WE ATTEND AT WHICH THERE ARE MEMBERS OF CONGRESS. I SPECIFICALLY WANTED TO READ YOU A STATEMENT THAT NOOET AH LOWY WHO IS THE HOUSE APPROPRIATIONS COMMITTEE SHA CHAIR SAID APRIL SECOND. I DIDN'T WRITE IT DOWN BUT IT APPEARED ONLINE I THOUGHT YOU WOULD LIKE TO KNOW THIS SHE SAID QUOTE I WILL WORK AS HARD AS I CAN TO GIVE YOU AS MUCH MONEY AS WE CAN. YOU HAVE THE BRILLIANCE. YOU HAVE THE COMMITMENT, AND YOU HAVE THE DETERMINATION. ALL YOU NEED IS MORE MONEY. SO WE ARE VERY FORTUNATE TO HAVE A HOUSE COMMITTEE CHAIR WHO IS THINKING LIKE THAT. IT WAS REALLY A LOVE FEST. I MEAN, IT IS ALL ARCHIVED. YOU CAN GO ONLINE AND WATCH IT. IT IS REALLY QUITE INSPIRATIONAL TO GET THAT SUPPORT FROM THE HOUSE. SORRY. HOUSE APPROPRIATIONS SUB-COMMITTEE MARKED UP A BILL THAT GAVE $41.1 BILLION FOR NIH WHICH WAS AN INCREASE OF $2 BILLION. THAT SPECIFICALLY MEANS FOR US A BUDGET OF $1.58 BILLION THAT IS AN $80 MILLION INCREASE OVER THE PAST CURRENT FISCAL YEAR AND IT INCLUDES $12.6 MILLION FOR SUPPORT FOR GABRIELA MILLER KIDS FIRST PROGRAM. FULL COMMITTEE MARKUP WAS HELD MAY EIGHTH AND FIVE APROPRIATION BILLS INCLUDING LABOR HHS HAVE BEEN PACKAGED TOGETHER TO BE CONSIDERED ON THE HOUSE FLOOR THIS WEEK. WHY AM I TELLING YOU THAT? THAT IS WHY NIH DIDN'T SHUT DOWN WHEN THE GOVERNMENT SHUT DOWN. THEY CREATED SOMETHING CALLED A MINIBUS WHICH THEY TOOK AWAY PARTS OF THE GOVERNMENT THAT WERE NOT CONSIDERED TO BE SO CONTROVERSIAL AND WERE ABLE TO PASS THE BUDGET BEFORE OCTOBER 1ST. WHEN OCTOBER 1ST 2018 ROLLED AROUND, NIH FOR THE FIRST TIME I BELIEVE IN 22 YEARS OR SOMETHING LIKE THAT HAD -- COULD APPROACH THE YEAR WITH A FULL FISCAL BUDGET, WHICH IS -- I CANNOT TELL YOU HOW IMPORTANT THAT IS FOR OUR ABILITY TO PLAN FOR THE FISCAL YEAR. SO THEY ARE AT LEAST TRYING TO DO THAT AGAIN, WHICH IS ALSO POTENTIALLY GOOD NEWS FOR US. THEN THE SENATE, I WOULD SAY -- I WASN'T AT THE SENATE HEARING. I DID WATCH IT ON THE VIDEO CAST. IT WAS A BIT MORE MEASURED BUT STILL SUPPORT WAS EXPRESSED FOR NIH. THEIR MARKUP IS EXPECTED IN JUNE. SO GIVEN WE POTENTIALLY WILL HAVE MORE MONEY AND IT RELATES TO THE STRATEGIC PLANNING PROCESS. WE HAVE BEEN THINKING A LOT ABOUT WHERE CAN NICHD MAKE A DIFFERENCE? AS YOU KNOW, MATERNAL MORTALITY IS A SIGNIFICANT ISSUE IN THE UNITED STATES RIGHT NOW. ABOUT 700 PREGNANT OR PERIPARTUM WOMEN HAVE DIED IN THE PAST YEAR AS A CONSEQUENCE OF CHILDBIRTH THAT MEANS EVERY 12 HOURS A WOMAN IN THE UNITED STATES IS DYING DURING OR AFTER CHILDBIRTH. THE CDC RECENTLY PUBLISHED AN ANALYSIS THAT WAS VERY HELPFUL IN CLARIFYING SOME OF THE ISSUES. BASICALLY, A VERY STRONG MESSAGE WAS MATERNAL DEATH CAN HAPPEN UP TO A YEAR AFTER DELIVERY. IT IS IMPORTANT. CURRENTLY THERE ARE ALL KINDS OF DIFFERENCES IN THE WAY THAT STATISTICS ARE KEPT AND MORE IMPORTANTLY, CMS ONLY ALLOWS MATERNITY COVERAGE FOR 60 DAYS AFTER DELIVERY. 60% OF MATERNAL DEATHS ARE PREVENTABLE. WE HEARD IN A WORKSHOP WE HELD RECENTLY THAT I WILL SHOW YOU IN A SUBSEQUENT SLIDE IT THAT MANY OF THE WOMEN WHO NEED COVERAGE ARE NOT GOING TO A PHYSICIAN AFTER THEIR MEDICAID COVERAGE ENDS. THIS IS AN AREA WE CAN POTENTIALLY ALSO HAVE AN IMPACT BY PARTNERING WITH CMS. DATA PRESENTED BY CDC CONFIRMED THAT AFRICAN-AMERICAN WOMEN HAVE A MUCH HIGHER INCIDENCE OF DEATH AND THERE IS AN EFFECTIVE AGE AND THERE ARE DIFFERENT COMPLICATIONS DEPENDING WHEN YOU LOOK. SO IN THE IMMEDIATE PERIDELIVERY PERIOD IT IS MORE LIKE AMNIOTIC FLUID EMBOLISM OR HEMORRHAGE AND OVER TIME HEART DISEASE AND STROKE ARE IMPORTANT COMORBIDITIES AND UP TO POSTPARTUM CARDIOMI OP OJY IS A SERIOUS ISSUE. MATERNAL -- IT IS A PUBLIC HEALTH PRIORITY THAT FALLS NATURALLY WITHIN OUR PORTFOLIO. IT IS A SIGNATURE EFFORT OF OUR OFFICE OF HEALTH EQUITY. WE ARE SPONSORING AND WE HAVE SPONSORED ALREADY SEVERAL MEETINGS AIMED AT UPDATING THE RESEARCH AGENDA ON MATERNAL MORTALITY. APRIL 8TH COMMUNITY ENGAGEMENT FORUM ON MATERNAL HEALTH AND TALK FROM LA KWEND AH NEZ BIT DIRECTOR OF DEPARTMENT OF HEALTH THAT TOLD US WHAT THE CITY IS DOING. THE GOAL OF THIS PARTICULAR FORUM WAS TO GET COMMUNITY-BASED ENGAGEMENT AND INFORMATION ABOUT WHAT COMMUNITY GROUPS NEED TO INFORM OUR RESEARCH STRATEGY. THERE WERE MORE THAN 400 PARTICIPANTS IN THIS PARTICULAR FORUM IN PERSON AND ONLINE AND FACEBOOK RECEIVED 11,000 VIEWS IN THE FIRST WEEK FOLLOWING THE FORUM. WE HEARD VERY IMPORTANT MESSAGES FROM THE COMMUNITIES EFFECTED FROM ALL OVER THE COUNTRY. THEY WERE QUITE PLEASED THAT WE HAD ASKED FOR THEIR INPUT. SO WE ARE DOING A NUMBER OF THINGS IN PARALLEL. FOR EXAMPLE, OUR SPACE IS THE RESEARCH SPACE. WE ARE NOT IN THE BUSINESS OF MAKING RECOMMENDATIONS FOR CARE. WE ARE IF IN THE BUSINESS OF FUNDING THE RESEARCH THAT WILL GENERATE THE EVIDENCE TO INFORM PRACTICE RECOMMENDATIONS. SO A NUMBER OF OUR NICHD STAFF LED BY NAH HEAT AH CHUCK TORA HAVE SUBMITTED A MANUSCRIPT ACCEPTED FOR PUBLICATION FROM AMERICAN JOURNAL OF OBSTET TRICKS AND GYNECOLOGY ON IMPORTANCE OF RESEARCH OF MATERNAL MORBIDITY. VIEWPOINT ARTICLE IN NEW ENGLAND JOURNAL OF MEDICINE THEY TALKED ABOUT MORTALITY AND DIDN'T MENTION RESEARCH AT ALL NEVER ONCE. WE THOUGHT IT WAS VERY IMPORTANT TO HAVE A COMPLIMENTARY COMMENTARY HOW WE CAN HELP. WE HAD ANOTHER WORKSHOP ON MAY 2ND. EXCUSE ME. ON MATERNAL MORTALITY IN THE UNITED STATES FUTURE RESEARCH DIRECTIONS AND THE GOAL WAS, AGAIN, TO GET MORE INFORMATION TO EVENTUALLY SHAPE A RESEARCH AGENDA AND DISCUSSIONS THERE INCLUDED DATA QUALITY AND TRENDS AND HEALTH DISPARITIES, PARTICULARLY THE RACIAL DIFFERENCES AND SOCIAL DETERMINANCE AND EFFECT OF INSTITUTIONAL RACISM AND CLINICAL CAUSES. IT WAS WAS A VERY RICH DISCUSSION. A REPORT WILL BE GENERATED FROM THAT, THAT WILL CERTAINLY INFORM US GOING FORWARD. I PREVIOUSLY MENTIONED CMS WHICH IS ALSO VERY INTERESTED IN MATERNAL MORBIDITY AND MORTALITY. WE HAVE ESTABLISHED A WORKING GROUP TO WORK WITH THEM TO SEE HOW WE CAN GET ACCESS TO THEIR DATA, PARTICULARLY STATE MEDICAID DATA TO INFORM OUR RESEARCH QUESTIONS. WE ARE ALSO SUPPORTING A NATIONAL ACADEMY OF SCIENCES AND ENGINEERING OF MEDICINE STUDY ON CHOICE OF BIRTH SETTINGS INCLUDING RISK FACTORS SOCIAL DETERMINANCE THAT INFLUENCE RISK AND MATERNAL OUTCOMES. THOSE RECOMMENDATIONS ARE EXPECTED IN 2020. WE WILL HOLD ONE FURTHER WORKSHOP IN EARLY 2020 ON THE ISSUE OF THE COMORBIDITIES THAT WOMEN EXPERIENCE AND HOW THEY PROVIDE RISK FOR MATERNAL MORTALITY. HOW CAN WE PREVENT SOME OF THE COMPLICATIONS? SO PREGNANCY AND LACTATION IS ANOTHER AREA. 6.3 WOMEN IF IN THE US BECOME PREGNANT EACH YEAR AND GREATER THAN 90% OF THEM TAKE MEDICATIONS. ONLY 70% OF THEM ARE PRESCRIBED. 98% OF MEDICATIONS HAVE INSUFFICIENT DATA TO DETERMINE THE RISK OF TEROGENICITY. 98% OF DOSING STUDIES DON'T INCLUDE PREGNANT WOMEN, HENCE THE NEED FOR THE TASK FORCE. PREGNANCY IS COMPLEX. PLAS ENTY CHANGES OVER TIME AND -- PHYSIOLOGICAL CHANGES IN PREGNANT WOMAN DUE TO PREG NANNY. DON'T KNOW MUCH ABOUT HOW A WOMAN METABOLIZES A DRUG BEFORE OR DURING PREGNANCY AND DON'T KNOW MUCH ABOUT THE IMPACT OF EXTERNAL FACTORS INCLUDING MATERNAL OBESITY AND ENVIRONMENT AND EFFECTS OF CHRONIC AND ACUTE CONDITIONS IN THE PREGNANT WOMAN AND THEIR CONCERNS REGARDING LIABILITY FOR THE DRUG COMPANIES. IT IS EVEN WORSE FOR LACTATION. HALF A MILLION WOMEN HAVE DIFFICULTY MAKING MILK. WE -- THERE IS VERY LITTLE KNOWN WITH REGARD TO MEDICATIONS IN BREAST MILK. THERE ARE VERY FEW ASSAYS FOR ASSESSMENT OF THIS. AS YOU HAVE HEARD PREVIOUSLY, NICHD WHICH IS MAINLY FOR NEWER MEMBERS OF COUNCIL, NICHD WAS CHARGED WITH DEVELOPING A TASK FORCE TO CREATE RECOMMENDATIONS AND TO SECRETARY AZAR AFTER FOUR MEETINGS AND MULTIPLE WORK BEHIND THE SCENES, THE REPORT WAS SUBMITTED TO THE SECRETARY IN SEPTEMBER OF 2018. THE KEY RECOMMENDATIONS INCLUDED CHANGING THE EXISTING CULTURE THAT HAS LIMITED SCIENTIFIC KNOWLEDGE OF THERAPEUTIC PRODUCT SAFETY, EFFECTIVENESS S, AND DOSING FOR PREGNANT AND LACTATING WOMEN WE WANT TO CHANGE THE CULTURE TO PROTECT WOMEN THROUGH NOT FROM RESEARCH AND -- VULNERABLE POPULATION THROUGH THE COMMON RULE AND EXPAND THE WORKFORCE OF CLINICIANS AND RESEARCHERS IN EXPERTISE IN OB STRET TRICK AND THERAPEUTIC -- BARRIERS THAT PREVENT RESEARCH IN THIS PARTICULAR POPULATION. ALL 15 OF THE RECOMMENDATIONS AND FULL REPORT, WHICH IS OVER 400 PAGES IS AVAILABLE ONLINE IF YOU CHOOSE TO READ IT. THERE IS ALSO AN EXECUTIVE SUMMARY. SO ONE OF THE RECOMMENDATIONS WAS TO EXTEND THE CHARTER SO WE COULD FOCUS ON IMPLEMENTING THE RECOMMENDATIONS. I MEAN, IT IS GREAT TO PRODUCE A REPORT, BUT IF NOTHING HAPPENS, IT IS SOMEWHAT FOR NOT. WE WERE VERY PLEASED AS THE SECRETARY AGREED TO ALLOW US TO CONTINUE WORKING IN THIS AREA AND PHASE 2 OR THE SEQUEL, AS WE CALL IT. WE WILL HOLD TWO MEETINGS OF THE FULL TASK FORCE PER YEAR AS REQUIRED IN THE NEW LEGISLATION. WE ALREADY HAVE HELD A CHARGE CALL. WE WILL HAVE A FULL IN-PERSON MEETING IN AUGUST. THE FOUR IMPLEMENTATION GROUPS ARE FOCUSING ON -- THERE IS A GROUP FOCUSING ON RESEARCH AND TRAINING AND ONE FOCUSING ON REGULATORY AND ONE FOCUSING ON COMMUNICATION AND ONE FOCUSING ON DRUG DISCOVERY AND HOW CAN YOU USE EXISTING DATA SETS, FOR EXAMPLE, TO DISCOVER NEW THERAPEUTICS. SO THE EXISTING MEMBERS OF THE TASK FORCE WERE DIVIDED UP INTO FOUR WORKING GROUPS WITH A GOOD MIX OF OLD AND NEW EXPERTISE. WE WILL FILL IN EACH WORKING GROUP WITH ADDITIONAL AD HOC MEMBERS AS NEEDED. WE HAVE STRONG FEDERAL PARTNERS IN THIS AREA AS WELL. IN PARTICULAR, FDA HAS BECOME QUITE INTERESTED IN MEDICATIONS TAKEN BY PREGNANT AND LACTATING WOMEN. THEY HAVE A NUMBER OF RECENT DRAFT GUIDANCES, INCLUDING SCIENTIFIC AND ETHICAL CONSIDERATIONS FOR INCLUSION OF PREGNANT WOMEN AND CLINICAL TRIALS AND CLINICAL LACTATION STUDIES CONSIDERATION FOR STUDY DESIGN AND POST APPROVAL PREGNANCY SAFETY STUDIES GUIDANCE FOR THE INDUSTRY. THEY HAVE ALSO ESTABLISHED AN FDA CENTER FOR EXCELLENCE FOR PERINATAL AND MATERNAL HEALTH. FDA AND END USER TESTING APPROVALS TO -- TESTING PLACENTAL DRUG TRANSFER USING TISSUE CHIPS. WE HAVE STRONG FDA REPRESENTATION ON PREGLAC TASK FORCE. IT IS GREAT WE CAN PARTNER WITH CMS AND MATERNAL MORTALITY AND FDA ON PREGLAC AND ACTION IS NIH INCLUDE PROJECT. FOR THOSE THAT NOE DON'T KNOW WHAT INCLUDE IS IT IS A TRANSNIH THAT WAS INCLUDED IN CONGRESSIONAL 2018 BUDGET LEGISLATION AND INCLUDE IS AN ACRONYM FOR INVESTIGATING CO-OCCURRING CONDITIONS OF LIFE SPANS SPAN TO UNDERSTAND DOWN SYNDROME INVESTIGATE CONDITIONS THAT EFFECT INDIVIDUALS WITH DOWN SYNDROME AS WELL AS THE GENERAL POPULATION. SPECIFICALLY TO LOOK FOR CONDITIONS THAT PEOPLE WITH DOWN SYNDROME HAVE COMMONLY AND USE THAT POPULATION TO INFORM POPULATIONS THAT DON'T HAVE DOWN SYNDROME. PERFECT EXAMPLE FOR EXAMPLE IS ALZHEIMER'S DISGUISE INVARIABLY PEOPLE WITH DOWN SYNDROME GET ARLZ HIEMERS DISEASE BECAUSE OF THE HIGH PREVALENCE THEY CAN BE STUDIED AND HOPEFULLY INSIGHTS FROM THE POPULATION WILL INFORM POPULATIONS THAT DON'T HAVE DOWN SYNDROME. WOI LIKE TO MENTION A NUMBER OF PEOPLE FROM NIH AND I JUST RETURNED YESTERDAY FROM THE THIRD INTERNATIONAL TRIES OHMY 21 RESEARCH SOCIETY MEETING IN BARCELONA WHICH WAS AMAZING. CLOSE TO 400 PECHL WERE THERE AND INCLUDING PEOPLE THAT HAVE DOWN SYNDROME. THE MOST I THINK MEANINGFUL PART OF THE MEETING FOR ME WAS HEARING ADULTS THAT HAVE DOWN SYNDROME PERSONALLY SPEAK ABOUT THEIR FEELINGS ABOUT PARTICIPATING IN RESEARCH. IT -- I MEAN, THE SCIENCE HAS REALLY MOVED QUITE FAR IN THE LAST TWO YEARS. THERE -- IT WAS VERY INTERESTING TO SEE HOW SPAIN HAS INCORPORATED PEOPLE WHO HAVE DOWN SYNDROME INTO THE CULTURE AND REALLY THEY ARE QUITE ADVANCED IN TERMS OF CARE THERE. SO THE INCLUDE PROJECT HAS THREE COMPONENTS TO ADDRESS KEY QUALITY OF LIFE ISSUES. NO. 1, IT IS TO CONDUCT HIGH RISK AND HIGH REWARD BASIC SCIENCE STUDIES ON CHROMOSOME 21. NO. 2 IS TO ASSEMBLE LARGE STUDY POPULATION WITH INDIVIDUALS WITH DOWN SYNDROME AND INCLUDE THEM IN EXISTING CLINICAL TRIALS. SORRY. THAT IS THE THIRD ONE. INCLUDE INDIVIDUALS WITH DOWN SYNDROME AND EXISTING CLINICAL TRIALS. THIS UNIQUE DOUBLE BENEFIT OF THE STUDY IS TO UNDERSTAND BOTH DOWN SYNDROME AND SHARED COMMON CONDITIONS SO BOTH ADDRESSING RISKS AND RESILIENCIES. SO CLOSE TO 23 MILLION I THINK WAS THE FINAL NUMBER THAT WAS AWARDED IN FISCAL YEAR 18 AND NICHD SPECIFICALLY HAS ISSUED FOR FUNDING OPPORTUNITY ANNOUNCEMENTS IN FISCAL YEAR 19. THESE REWARDS WILL BE MADE BY SEPTEMBER. THERE ARE ALSO WORKSHOPS AND DEVELOPMENT THAT INCLUDE PLANNING OF VIRTUAL DOWN SYNDROME COHORT ACROSS THE LIFESPAN AND STATE OF THE SCIENCE FOR MEANINGFUL CLINICAL TRIALS IN DOWN SYNDROME. IN ADDITION BECAUSE OF NICHD'S STRONG SUPPORT OF INTELLECTUAL DISABILITIES, WE ARE DESIGNING A NEW PROJECT THAT WILL LEVERAGE THE NICHD'S EXISTING PEDIATRIC CLINICAL TRIALS TO ESTABLISH AN INFRASTRUCTURE TO TEST THERAPEUTICS IN PEOPLE WHO HAVE DOWN SYNDROME. IN ADDITION BECAUSE OF THE COMPLEXITIES AND SOME UNIQUE CONSIDERATIONS OF EVALUATING PEOPLE WHO HAVE INTELLECTUAL DISABILITY, WE ARE DEVELOPING TRAINING PROGRAMS ON EFFECTIVE WAYS FOR PRACTITIONERS TO WORK WITH POPULATIONS OF PEOPLE WHO HAVE INTELLECTUAL AND DEVELOPMENTAL DISABILITIES. SO ANOTHER UPDATE IS YOU HEARD ME TALK PREVIOUSLY ABOUT THE DATA AND SPECIMEN HUB, WHICH IS JUST YOU KNOW EXPLODING. IT HAS NOW 35 DIFFERENT STUDY TOPICS. FOR THOSE THAT ARE NEW TO COUNCIL, IF YOU GO TO DASH NICH.NIH.GOV IT IS AN EASY SITE IF INTERESTED IN STILL BIRTH FOR EXAMPLE YOU CLICK ON STILL BIRTH AND THERE IS A BRIEF DESCRIPTION OF STUDIES THAT HAVE BEEN PERFORMED AND TYPES OF DATA THAT HAVE BEEN AVAILABLE AND DATA IS CLEANED AND ANONYMIZED. IT IS A TERRIFIC OPPORTUNITY FOR TRAINEES AND YOUNG INVESTIGATORS TO DEVELOP A HYPOTHESIS AND NOT HAVE TO WORRY ABOUT GOING THROUGH THE IRB AND RECRUITING PATIENTS. THIS IS AVAILABLE TODAY IF YOU WANT IT. SO IT HELPS NI -- INVESTIGATORS MEET NIH'S DATA SHARING REQUIREMENTS FOR THEIR OWN STUDIES AS THEY SHARE WITHIN DASH. IT HAS ITS OWN GOVERNANCE, BUT ITS GOAL IS REALLY TO FACILITATE SECONDARY QUESTINS OR SECONDARY ANALYSIS. THERE HAVE ALREADY BEEN 15 DATA USE POPULATIONS THAT ARE 134 STUDIES IN DASH. NOW, WHAT IS NEW AND ONE OF THE REASONS WE ARE PRESENTING IT HERE IS THERE ARE 8 STUDIES ALSO OFFERING BIOSPECIMENS. IF YOU LOOK AT THE UPPER LEFT THERE YOU CAN GET AMNIOTIC FLUID, BLOOD, BREAST MILK, DNA AND RNA IN PROTEINS SALIVA AND SERUM PLASMA AND TISSUE AND URINE AND VAGINAL FLUID. AGAIN, FOR A YOUNG INVESTIGATOR TO BE ABLE TO GET THE MATERIAL QUICKLY IS REALLY TRANSFORMATIVE. HERE SOME NEW INITIATIVES THAT ARE IN THE STUDY OR DATABASE RATHER AND THERE IS A NEW FUNCTION FOR DASH THAT IS MANAGING THE REQUESTS FOR THE BIOSPECIMENS THAT COME IN. THIS IS PART OF THE INSTITUTE COMMITMENT TO DATA SHARING AND BIOSPECIMEN SHARING. THIS IS SOMETHING THAT WE WILL BE INCORPORATING AS WE FUND FUTURE STUDIES. WE WANT TO MAKE SURE THERE IS A COMMITMENT TO PUT EVERYTHING BACK INTO DASH. AND SO HERE, JUST EXAMPLES OF SOME OF THE PUBLICATIONS FROM THE REUSE. MANY OF THEM HAVE TO DO WITH A STUDY THAT WAS DONE ON PROGRESSION DURING LABOR. THERE HAS BEEN AN ENORMOUS AMOUNT OF INTEREST IN THAT PARTICULAR STUDY. SO JUST IN CLOSING, I WANT TO GIVE YOU SOME UPDATES ON SOME NEW LEADERSHIP AT NIH. WE HAVE A NEW DIRECTOR FOR THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS THAT IS DEBORA TUCI. SHE PRONOUNCES IT TO SEE. SHE WILL JOIN NIH IN SEPTEMBER AND COMES FROM COMMUNICATION SCIENCES AT DUKE UNIVERSITY. I WAS ON THIS PARTICULAR SEARCH COMMITTEE. I CAN ASSURE YOU, SE IS A TERRIFIC PERSON. WITH HER RECRUITMENT, THERE ARE NOW 10 OF 27 DIRECTORS AT NIH THAT ARE WOMEN. SO THAT IS QUITE AN INCREASE. JUST FOR THE NEW PEOPLE, AGAIN, WE MADE A LIST BECAUSE THE FEMALE DIRECTOR -- THIS IS SOMETHING THAT IT IS NOT GENERALLY KNOWN. THAT IS WHY I'M MENTIONING IT. WE NOW HAVE 10 DIRECTORS WHO ARE WOMEN. WE TALK A LOT ABOUT THE POWER OF 10 AND WHAT THAT MEANS IN TERMS OF DISCUSSIONS AT LADERSHIP OPPORTUNITIES. LASTLY, WE ARE HIRING. I JUST WANT TO GIVE YOU AN UPDATE ON SOME OF OUR MAJOR HIRES. FOR OUR EXECUTIVE OFFICER, SO THE EXECUTIVE OFFICER ESSENTIALLY IS THE TOP ADMINISTRATIVE BUSINESS PERSON IN THE INSTITUTE. JOHN JARMAN RETIRED ABOUT A YEAR AGO. WE ARE IN THE FINAL STAGES OF HIRING A PERMANENT NEW EXECUTIVE OFFICER WITH THE DEPUTY DIRECTOR POSITION. INTERVIEWS HAVE BEEN CONCLUDED. WE ARE FINALIZING SOME REFERENCE CHECKS AND WE HOPE TO HAVE A DECISION SOON THERE. AND THEN EXTRAMURAL BRANCH CHIEF POSITIONS IN PREGNANCY AND PERI-NATOLOGY CHILD DEVELOPMENT AND BEHAVIOR AND OBSTET TRICK THERAPEUTIC PHARMACOLOGY AND THERAPEUTICS AND WE HAVE OPPORTUNITIES FOR MEDICAL PROGRAM OFFICERS IN DIVISION OF EXTRAMURAL RESEARCH. WE ENCOURAGE IF YOU HAVE PEOPLE IN YOUR FACULTIES FOR EXAMPLE THAT ARE INTERESTED IN RESEARCH AND DON'T WANT TO RUN THEIR OWN LABORATORY, THIS IS ANOTHER WAY FOR THEM TO SHAPE SCIENCE AND STILL STAY VERY MUCH CONNECTED WITH A SCIENTIFIC AGENDA AND YET NOT BE A PI. WE ARE ALWAYS LOOKING FOR GREAT PEOPLE. THAT IS THE DIRECTOR'S REPORT. I'M HAPPY TO TAKE QUESTIONS. THANK YOU. QUESTIONS? MELISSA, WELCOME BACK. >> I'M HAPPY TO BE BACK. THANK YOU SO MUCH FOR YOUR REPORT. I WAS EXCITE D TO SEE EMPHASIS ON MATERNAL MORTALITY AND HEALTH DISPARITIES I WONDERED IF THERE WAS INFORMATION ON POSTPARTUM CONTRACEPTION AND BIRTH SPACING AS A MECHANISM FOR REDUCING MATERNAL MORTALITY. >> DIANA BIANCHI: WITH REGARDS SPECIFICALLY TO MATERNAL MORTALITY IT DIDN'T COME UP TO MY KNOWLEDGE I WAS AT MOST OF THEPHORA. IT IS VERY MUCH PART OF THE DISCUSSIONS REGARDING OUR STRATEGIC PLANNING. IT IS VERY MUCH IMBEDDED INTO WHAT WE ARE PLANNING TO DO. OKAY. WE WILL MOVE ALONG THEN. DR. HANN WILL PRESENT OUR NEW COUNCIL MEMBERS. >> DELLA HANN: IT IS MY PLEASURE TO DO THAT THIS MORNING TO WELCOME FOLKS JOINING US TO SERVE ON OUR ADVISORY COUNCIL. WHAT I WILL DO IS IF YOU ARE LISTED ALPHABETICALLY THERE IS NO OTHER ORDER WITH REGARD TO THIS. AS I CALL YOUR NAME EACH OF YOU PROVIDE US WITH A BRIEF ININTERESTED UKT AND SUMMARY OF PROFESSIONAL BACKGROUND IN ALPHABETICAL ORDER I WOULD LIKE TO WELCOME DR. MICHELLE CAGANA. >> THANK YOU VERY MUCH. I'M FROM THE NEW YORK STATE DEPARTMENT OF HEALTH AND RUN NEWBORN SCREENING PROGRAM THERE AND INTEREST IS IN PUSHING TECHNOLOGY AND PERFORMING PILOT STUDIES IN NEWBORN SCREENING AND WE RECEIVED FUNDING AND I'M EXCITED TO BE HERE. THANK YOU. >> DELLA HANN: NEXT, WELCOME TO DR. MARTIN MATZUK. I'M DIRECTOR AND PROFESSOR DEPARTMENT OF PATHOLOGY AND IMMUNOLOGY AND -- AND MY FUNCTIONS AS DIRECTOR, I HAVE BEEN DOING IT THAT WORK FOR THE LAST SIX YEARS. RESEARCH FOCUS IS IN REPRODUCTIVE MEDICINE AND CONTRACEPTION. >> DELLA HANN: WELCOME. NEXT IS KARMEN NEW-BERGER. >> GOOD MORNING. IT IS A WONDERFUL OPPORTUNITY TO BE HERE. I'M CARME NEWBERGER EXECUTIVE COUNCIL AT PHOENIX HOSPITAL WHICH IS ARIZONA'S ONLY FREE-STANDING CHILDREN'S HOSPITAL. PRIOR TO BEING AN ATTORNEY I WAS A NURSE AT GEORGE WASHINGTON UNIVERSITY HOSPITAL WORKING IN INTENSIVE CARE. I'M PRIMARILY RESPONSIBLE FOR THE LEGAL ENVIRONMENT IN OUR HEALTH CARE HOSPITAL SYSTEM AND IN QUALITY AND RISK MANAGEMENT AND GET INVOLVED IN PEDIATRIC RESEARCH AS WELL. IT IS A GREAT OPPORTUNITY TO BE HERE. THANK YOU. >> DELLA HANN: OKAY. WONDERFUL. THANK YOU. NEXT, WELCOME TO DR. ALLEN KITA. >> THANK YOU. MY NAME IS ALLEN TATA I'M FROM UNIVERSITY OF ALABAMA AT BIRMINGHAM AND I DIRECT CENTER FOR WOMEN'S GLOBAL HEAL MG AND WE DO RESEARCH OUT THERE AND ARE FORTUNATE TODAY BE WELL FUNDED BY NIH AND NICHD IN GENERAL. MY BACK GROUND IS -- IF YOU ARE WONDERING I'M A NATIVE OF CAMERON. >> DELLA HANN: GREAT. THANK YOU. NEXT DR. REBECCA WONG. >> HI. GOOD MORNING. I'M REBECCA WONG AND PROFESSOR AT UNIVERSITY OF TEXAS BRANCH IN GALVESTON AND BACKGROUND IS ECONOMIST AND POPULATION HEALTH SPECIALIST AND DEMOGRAPHER AND STUDY AGING IN LIFE PERSPECTIVE IN POPULATIONS IN LATIN LATIN AMERICA. IF YOU ARE WONDERING I'M FROM MEXICO. >> DELLA HANN: FINAL PERSON IS DR. ANTHONY WIN CHEL BOHR EZ. >> GOOD MORNING. I GO BY TONY. WHEN ANYBODY SAYS ANTHONY HAIR STANDS UP ON THE BACK OF MY NEXT. IT IS WHAT MY MOTHER SAID WHEN I WAS IN TROUBLE. -- AND ALSO UNIVERSITY HOSPITALS CLIVELAND MEDICAL CENTER DEPARTMENT HAS BASIC RESEARCH AND CLINICAL MEDICINE AND WE DO CLINICAL GENETICS FOR UNIVERSITY HOSPITALS. I WILL POINT OUT DR. BIANCHI WAS ONE OF MY ATTENDINGS AND TAUGHT ME MUCH OF WHAT I KNOW IN GENETICS. THANK YOU AND [INDISCERNIBLE] WAS IN DEPARTMENT WHEN I WAS POST DOC AT HARVARD AND TAUGHT ME LOTS OF WHAT I KNOW ABOUT GENETICS. NEUROGENETIC DISEASES AND IN CASE YOU WONDER I'M A NATIVE OF CLIVELAND. >> DELLA HANN: I'M GLAD THAT EVERYONE IS SHARING THEIR HERITAGE HERE THIS MORNING. THANK YOU ALL AND WELCOME ONCE AGAIN. WE LOOK FORWARD TO WORKING WITH YOU, EACH OF YOU, AND AS A GROUP. WOI LIKE TO TURN THE MEETING BACK TO DR. BIANCHI. >> DIANA BIANCHI: THANK YOU DELLA. WE VALUE THE ADVICE THAT WE RECEIVE FROM OUR COUNCILMEMBERS. I TOO AM LOOKING FORWARD TO WORKING WITH ALL OF YOU PARTICULARLY AS WE MOVE FORWARD WITH OUR NEW STRATEGIC PLAN. NEW COUNCIL MEMBERS WE HAVEN'T HAD A STRATEGIC PLAN THAT IS NEW SINCE EARLY 2000. THIS IS AN IMPORTANT TIME AT WHICH YOU ARE JOINING US. WE HOPE IT WILL REVITALIZE US AS WELL AS YOU WILL HEAR TODAY A ROLLOUT OF OUR NEW OR PROPOSED NEW MISSION AND VISION STATEMENTS. I WILL TALK ABOUT THAT LATER THIS MORNING. NOW, WE WOULD LIKE TO HEAR FROM DELLA WITH THE EXTRAMURAL RESEARCH REPORT. >> DELLA HANN: HERE IT GOES. GOOD MORNING, AGAIN. FOR NEWER MEMBERS, I USUALLY GIVE A BRIEF OVERVIEW OF VARIOUS EVENTS AND ISSUES AND TOPICS RELEVANT TO EXTRAMURAL RESEARCH PROGRAM. THIS MORNING WILL BE NO DIFFERENT WITH REGARD TO THAT. LET'S SEE. THERE WE GO. ACTUALLY, I WILL SPEND MOST OF MY TIME ADDRESSING TWO TOPICS THAT CAME UP AT OUR LAST COUNCILMEMBER MEETING IN JANUARY. THE FIRST WERE ISSUES WITH REGARD TO THE INCLUSION OF THE INTELLECTUAL AND DEVELOPMENTAL DISABILITIES POPULATIONS IN CLINICAL RESEARCH. I WILL SPEND A LITTLE TIME TALKING ABOUT SOME OF THOSE EFFORTS AND OPEN IT UP FOR DISCUSSION BRIEFLY THEN AND THEN I WILL MOVE ON TO ANOTHER QUESTION THAT WAS RAISED. HAVING TO DO WITH THE PROVISION OF LONG TERM SUPPORT FOR MERITORIOUS INVESTIGATORS. THIS IS THE DIFFERENT KINDS OF GRANT ACTIVITIES THAT WE HAVE TO BE ABLE TO SUPPORT HIGHLY MERITORIOUS RESEARCHERS AND FINALLY HOPEFULLY IF I HAVE THE TIME, I WILL BE ABLE TO GIVE YOU A FEW STAFFING UPDATES FROM EXTRAMURAL SO TURNING TO FIRST ISSUE INCLUSION OF IDD POPULATIONS IN CLINICAL RESEARCH. AT THE LAST COUNCIL MEMBER, THIS CAME UP WITH REGARDS TO QUESTIONS TO THE EXTENT TO WHICH THIS PARTICULAR POPULATION MAY BE EXCLUDED FROM CLINICAL RESEARCH EFFORTS. WHEN I'M SPEAKING ABOUT CLINICAL RESEARCH, I'M TALKING ABOUT A VERY BROAD SPECTRUM THAT INCLUDES THE TRIALS AND ALSO INCLUDES MORE EPIDEMIOLOGICAL RESEARCH OR ANY OTHER KIND OF INTERACTIVE BEHAVIORAL RESEARCH THAT IS DONE WITH IDD POPULATIONS OR INCLUDES IDD POPULATIONS. WHAT I WANTED TO DO IN TERMS OF ADDRESSING THIS IS TO HELP SORT OF SET THE STAGE IN THE FRAME OF WHERE THIS POPULATION FALLS IN TERMS OF EFFORTS NOT ONLY HERE AT NICHD AND MORE BROADLY AT NIH. SO THE FIRST PLACE THAT WE LOOKED, I THINK MANY OF YOU MAY BE FAMILIAR WITH THIS. THIS IS THE RESEARCH CONDITION AND DISEASE CATEGORY SYSTEM THAT THE NIH EMPLOYS. THIS IS PUBLIC OFF OF PUBLIC WEBSITE AT NIH. INFORMATION ON THIS SLIDE IS PUBLICLY AVAILABLE. WE PULL DOWN ESSENTIALLY THE INFORMATION WITH REGARD TO ALL OF NIH AND AMOUNT OF FUNDING THAT IS GOING TO THE DIFFERENT EFFORTS. AGAIN, FOR CONTEXT SETTING PURPOSES, WE PULLED DOWN THE INFORMATION RELEVANT TO MANY OF THE POPULATIONS OF GREATEST TO THE INSTITU INSTITUTE. THERE IS MANY. THIS IS QUITE AN EXAMPLE. YOU WILL SEE ACROSS NIH THERE IS A COMMITMENT OF NEARLY $5 BILLION DEVOTED TO WOMEN'S HEALTH FOR PEDIATRIC RESEARCH IT IS ALMOST AS MUCH, 4.99 BILLION. WHERE IS ALEXAS. SHE DOESN'T LIKE ME TO GO OVER THREE DECIMAL PLACES THEY DO IT ON NRD SYSTEM. INTELLECTUAL AND DEVELOPMENTAL DISABILITIES 15 MILLION FOR PREGNANCY AND 419 -- [AUDIO CUT] OR THE PHASE OF THE TRIAL OR EVEN IN TERMS OF AGE RANGE. AGAIN, THIS IS SPECIFIC TO NICHD. AND THE INFORMATION THAT WE PULLED WAS -- WE FELT PRETTY GOOD ABOUT IT. IF IN TERMS OF IT WAS A SAMPLING IT MATCHED ESSENTIALLY OTHER WORK THAT HAS BEEN PUBLISHED LOOKING AT CLINICAL TRIALS DATABASE AND THAT KIND OF THING. IN ADDITION TO THAT, I WANTED TO THEN TALK ABOUT SOME OF OUR ONGOING EFFORTS THAT ACTUALLY DR. BIANCHI TOUCHED ON -- WORKING EITHER WITH OTHER AGENCIES OR WORKING ACROSS THE INSTITUTES TO MAKE THE ISSUE SALIENT AND TO BRING IT TO PEOPLE'S ATTENTION. SO I THINK THAT THE FIRST OF THESE IS ACTUALLY A GREAT EXAMPLE OF THIS. EXCUSE ME. HERE AT NIH FOR A NUMBER OF YEARS, WE HAVE A COMMITTEE CALLED THE INCLUSION GOVERNANCE COMMITTEE. WHAT THIS IS ARE REPRESENTATIVES FROM SEVERAL INSTITUTES, NOT ALL OF THEM. BUT SEVERAL INSTITUTES WHO WORK TOGETHER WITH THE OFFICE ON WOMEN'S HEALTH AS WELL AS -- AND, OF COURSE, IT ALSO INCLUDES THE NATIONAL INSTITUTE OF MINORITY AND HEALTH DISPARITIES AND IT HAS ROTATIONS ESSENTIALLY IN TERMS OF MEMBERSHIP. AGING INSTITUTE IS REPRESENTED AND WE HAVE A FIGURAL SEAT ESSENTIALLY ON THE GOVERNANCE COMMITTEE AND DR. JAMES GRIFFIN IN THE BACK HERE, ONE OF OUR FOLKS IN THE DIVISION IS ACTUALLY OUR REPRESENTATIVE ON THIS GROUP. HE AS WELL AS WITH LOOEZ AH KAZER HAVE BEEN VERY ACTIVE. THIS GROUP IS VERY IMPORTANT. IT IS THE GROUP THAT HELPS SET THE POLICIES AND WAYS THAT WE WILL IMPLEMENT VARIOUS POLICIES WITH REGARDIN COLLUSION ACROSS NIH NOT JUST SPECIFIC TO THE INSTITUTE BUT ACROSS INSTITUTES. THIS IS A GROUP THAT HELD A VERY FORMATIVE CONFERENCE IT WAS JUST A YEAR AGO, RIGHT, LISA? THE CONFERENCE? I THINK IT WAS ABOUT A YEAR AGO. IT HELD A VERY FORMATIVE CONFERENCE WITH REGARDS TO THE INCLUSION OF AGENCY AGE IF YOU FILLED OUT GRANTS LATY THERE IS EMPHASIS ABOUT DESCRIBING THE AGE OF YOUR HUMAN COHORT YOU WILL BE WORKING WITH. THOSE INSTRUCTIONS ESSENTIALLY AND POLICY FOR THE GRANT APPLICATIONS, THAT CAME AND ORIGINATED FROM THIS GROUP. HAVING A SEAT AT THE TABLE ON THIS PARTICULAR GROUP AND ALWAYS PUTTING TO THE FOREFRONT ESSENTIALLY THE POPULATIONS OF INTEREST TO THIS INSTITUTE BE THEY CHILDREN OR PREGNANT AND LACTATING WOMEN AND INTELLECTUAL AND DEVELOPMENTAL DISABILITIES IS VERY IMPORTANT AND THROUGH THE EFFORTS THAT WE ARE ABLE TO LIFT BOATS ESSENTIALLY ACROSS INSTITUTES AND NOT JUST HERE AT NICHD. ANOTHER IMPORTANT EFFORT DR. BIANCHI PROVIDED INFORMATION ON IS INCLUDE COOCCURRING CONDITIONS ACROSS THE LIFESPAN FOR UNDERSTANDING DOWN SYNDROME. WITH REGARD TO INCLUSION, I THINK THERE ARE A COUPLE POINTS I WANT TO HIGHLIGHT. FIRST AND CERTAINLY NOT LEAST AT ALL HAS TO DO WITH THE AMOUNT OF FUNDING COMING IN THROUGH THE INCLUDE PROGRAM. DIANA ALREADY INDICATED THERE IS 23 MILLION THAT HAS BEEN ADDED ESSENTIALLY TO LOOK AT THIS POPULATION AS YOU KNOW FROM OUR MEMBERS ON COUNCIL WHO HAVE BEEN WITH US FOR A WHILE FUNDING OPPORTUNITY ANNOUNCEMENTS WERE BROUGHT HERE IN TERMS OF THEIR CONCEPTS. WE ANTICIPATE ADDITIONAL FUNDS COMING IN THIS YEAR THROUGH THIS EFFORT ALONE. AGAIN, WHOLE IDEA TOO IS THAT WE ARE LOOKING AT UNDERSTANDING CONDITIONS THAT ARE PERTINENT TO A NUMBER OF OUR SISTER INSTITUTES. WE ARE AGAIN PARTNERING WITH SISTER INSTITUTES HEART AND LUNG AND BLOOD INSTITUTE AND AGING INSTITUTE TO MAKE SURE THIS PROP LISTING AND ITS MEDICAL CONDITIONS AND HEALTH ISSUES ARE RECOGNIZED AND ARE PART ESSENTIALLY OF NOT JUST THIS PORTFOLIO HERE AT NICHD BUT ACROSS MANY PORTFOLIOS AT NIH AND DIANA INDICATED SOME WORKSHOPS THEY WILL BE WORKING ON AND ONE I THINK THAT IS IMPORTANTIN COLLUSION ISSUE HAS TO DO WITH TRAINING OF PRACTITIONERS AND THOSE WORKING WITH INTELLECTUAL AND DEVELOPMENTAL DISABILITIES. WE HAVE AN IF NUMBER OF FOLKS THAT HAVEN'T NECESSARILY HAD MUCH CONTACT WITH THE POPULATION AND BEING ABLE TO MAKE PEOPLE FEEL EQUIPPED TO WORK WITH THE POPULATION WILL ONLY ENHANCE THEREFORE THE PROBABILITY OF INCLUDING THEM, THOSE INDIVIDUALS IN OUR DIFFERENT KINDS OF RESEARCH PROGRAMS. I THINK THAT IS ACTUALLY A HUGE BOOST THAT WILL HAVE VERY LONG-TERM EFFECTS. THIRD THING THAT I WANTED TO HIGHLIGHT BECAUSE IT IS INCREDIBLY IMPORTANT IS IT HAS TO DO WITH THE FACT OF -- THIS INSTITUTES VERY LONGSTANDING COMMITMENT TO INTELLECTUAL AND DEVELOPMENTAL DISABILITIES. WE HAVE A WHOLE RESEARCH BRANCH IN THE EXTRAMURAL PROGRAM DEVOTED ESSENTIALLY TO THE TOPIC AND THROUGH TREMENDOUS EFFORTS OF DR. MEL IS AH PERESEE WHO IS BRANCH MANAGER FOR THAT AS WELL AS HER GREAT STAFF THAT WORK WITH HER WE SHOW TREMENDOUS LEADERSHIP ACROSS NIH IN STUDYING AND DOING RESEARCH, SUPPORTING RESEARCH, RESEARCH TRAINING, AND ALL INFRASTRUCTURE THAT IS NEEDED FOR THAT RESEARCH TO UNDERSTAND, PREVENT, AND HOPEFULLY SOME DAY AMELIORATE INTELLECTUAL AND RELATED DEVELOPMENTAL DISABILITIES. INDEED, I THINK THE INCLUDE PROGRAM WOULD NOT -- WOULD BE VERY DIFFICULT IF WE DID NOT HAVE ALREADY THIS TORT OF FORCE ESSENTIALLY WE CAN RELY UPON TO REALLY HELP TO FORTH AHEAD IN THIS AREA. THAT IS A VERY QUICK OVERVIEW OF WHAT WE ARE DOING AND WHAT THE STATUS IS ESSENTIALLY OF THE INCLUSION OF THE POPULATIONS AS WELL AS WHAT WE ARE DOING IN ORDER TO ENHANCE RESEARCH AND INCLUSION IN THE POPULATION. I WANTED TO BREAK VERY QUICKLY TO SEE IF THERE WERE ANY COMMENTS OR QUESTIONS FROM COUNCIL. YES? >> THANK YOU. ANET. I HAD A QUESTION ABOUT THE ANALYSIS YOU DID ON CLINICAL TRIALS.GOV90% OF THE STUDIES DIDN'T EXCLUDE IDD POPULATIONS WERE YOU SURPRISED? DID YOU THINK IT WOULD BE SMALLER. THANKS. >> DELLA HANN: I WASN'T OVERLY SURPRISED. FOCUS WAS ON NICHD. I THINK WITH REGARD TO OUR EF ORT O ORITIES I THINK WE -- THAT DIDN'T NECESSARILY SURPRISE ME. >> ACROSS NIH WE DID A DIFFERENT STUDY LOOKING AT PHASE 3 AND 4 CLINICAL TRIALS ACROSS NIH SPECIFICALLY FOR INCLUSION OR EXCLUSION WITH PEOPLE OF INTELLECTUAL AND DEVELOPMENTAL SDANLTS PREGNANT WOMEN AND CHILDREN AND PEOPLE OVER 6558% OF THE POPULATION WAS EXCLUDED. I THINK IT REFLECT INTERESTS. THAT IS WHY WE ARE MORE INCLUSIONSIVEI INCLUSIVE. IF YOU DID THE STUDY ACROSS NIH IT WOULD BE DIFSH. >> IF YOU LOOKED AT THE SUBSAMPLE THAT DID INCLUDE AND DRILLED DOWN AND DID A REPRESENTATIVE SAMPLE HOW MANY ARE ACTUAL ENROLLING IN IT AND WHAT KIND OF A RATE. HAVE YOU LOOKED AT IT BEFORE? >> NO. WE HAVE NOT. IT IS SOMETHING THAT WE COULD EXPLORE, CERTAINLY. WE COULD CERTAINLY LOOK AT IT AND IT WOULD TAKE A BIT OF ELBOW GREECE ESSENTIALLY DATA IS BASICALLY TEXT DATA WE HAVE TO GO THROUGH AND TO READ. ANY ADDITIONAL COMMENTS OR QUESTIONS? OKAY. WITH THAT, I WILL TURN TO THE SECOND ISSUE THAT WAS RAISED AT OUR COUNCIL MEETING BACK IN JANUARY, WHICH WAS THE WAYS THAT NICHD PROVIDES LONG TERM SUPPORT FOR MERITORIOUS INVESTIGATORS. THIS CAME THROUGH SEVERAL CONVERSATIONS, I BELIEVE, THAT WE HAD HERE ON VARIOUS KINDS OF GRANT TOOLS AND GRANT MECHANISMS THAT WE USE TO DO THAT KIND OF SUPPORT. I BELIEVE THAT WE HAVE HAD 100% TURNOVER SINCE 20152016 COUNCIL. MAYBE MELISSA AND BARB WERE HERE FOR PIECES OF THAT. LE THERE WAS A WORKING GROUP OF COUNCIL DURING THAT PERIOD OF TIME IN FACT I BELIEVE THAT THERE BIANCHI WHEN SHE WAS WITH COUNCIL WAS PART OF THAT GROUP TOOK A LOOK OF A RELATIVELY NEW MTHOD OR GRANT MECHANISM THAT NIH DEVELOPED TO SUPPORT LONGER TERM SUPPORT FOR MERITORIOUS RESEARCH THAT IS CALLED R35. LY GO INTO MORE DETAIL ABOUT WHAT THAT IS HERE IN A SECOND. AT THAT TIME OBVIOUSLY GOING BACK IN TIME ONE HAS TO REMEMBER THE CONTEXT AND WHERE WE WERE. BACK IN 2015 AND 2016, THOSE WERE DIFFICULT YEARS WITH REGARD TO THE BUDGET. OUR PAY LINE HERE AT NICHD WAS PRETTY RESTRICTED. AND THERE WERE LOTS OF CHANGES IN THE WIND GOING ON WITH THE BUDGET AS WELL AS EFFORTS BY ALL OF THE INSTITUTES TO FIGURE OUT HOW BEST TO USE THEIR PRECIOUS DOLLARS DURING THAT PERIOD OF TIME. SO THE COUNCIL AT THAT TIME DID NOT RECOMMEND PURSUING THE R35. HOWEVER, THEY ALSO AGREED THAT WE REALLY SHOULD COME BACK AND TAKE A LOOK AT IT TO SEE FIRST OF ALL WHAT IT IS DOING AND THOSE INSTITUTES THAT WERE ACTUALLY USING IT AND HOW THE PROGRAM WAS GOING AS A WHOLE. THAT IS WHAT WE WERE GOING TO DO. SO, AGAIN, VERY QUICKLY, AS AN OVERVIEW, AND AGAIN FOR CONTEXT SETTING, EVERYONE I BELIEVE IN THE ROOM IS FAMILIAR WITH THE GRANDDADDY UP THERE RO1 WHICH IS STANDARD RESEARCH PROJECT GRANT. IT IS EVALUATED PRIMARILY WITH REGARD TO THE RESEARCH. THAT IS THE FOCUS IS THE RESEARCH THAT IS BEING PROPOSED IN THE RO1. OBVIOUSLY, INVESTIGATIVE TEAM IS OBVIOUSLY VERY IMPORTANT BUT THRUST IS ON LOOKING AT THE RESEARCH AND MAKING SURE THAT THE RESEARCH IS HIGHLY MERITORIOUS. THE R37 WAS INSPIRED THROUGH TWO OF THE INSTITUTES YOU WILL SEE ON ANOTHER SLIDE THAT WAS THE NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES, NIGMS AS WELL AS THE CANCER INSTITUTE. IN 2014, 2015, AGAIN, BECAUSE THOSE WERE YEARS WHERE FUNDING FOR NIH WAS SORT OF LEVEL AND FOLKS WERE TRYING TO FIGURE OUT HOW BEST WE COULD DO WITH WHAT WE HAD. THOSE TWO INSTITUTES WERE INSPIRED TO CREATE THE R37 MECHANISM. FOCUS FOR R37 MECHANISM IS BASED ON THE INVESTIGATOR. LOOKING AT THE HISTORY OF THE INVESTIGATOR AS WELL AS OBVIOUSLY THE QUALITY OF THE RESEARCH THAT COMES FROM THAT INVESTIGATOR AND PROVIDING A MEANS TO PROVIDE SUPPORT FOR MORE THAN 5 YEARS FOR -- EXCUSE ME. I'M TALKING ABOUT R35. I SKIPPED AHEAD. I DO APOLOGIZE. I WILL CONTINU ON R35. THAT WAS THEIR EFFORT TO DO LONGER TERM SUPPORT FOR OUTSTANDING INVESTIGATORS. GENERALLY AS YOU WILL SEE ON THE NEXT SLIDE THIS IS UP TO EIGHT YEARS IS THE LENGTH OF TIME. OFTEN TWO IN TERMS OF THE APPLICATION PROCESS, THE APPLICATIONS ARE DIFFERENT. THE PERSON IS NOT EXPECTED TO TALK ABOUT A SPECIFIC SET OF RESEARCH PROJECTS BUT IN TERMS OF THEMATIC RESEARCH THAT THEY ARE PURSUING IN THEIR LAB OR SPACE. IN ADDITION TO WHICH I THINK MANY ARE FAMILIAR WITH R37 AND I APOLOGIZE FOR THE CONFUSION. R37 IS METHOD TO EXTEND RESEARCH IN TIME. R37 IS PART OF NIH TOOL FS FOR MANY YEARS AND PROBABLY OVER 20 YEARS. THIS TOO IS A RECOGNITION THAT TRYING TO FIND A WAY TO EXTEND MERITORIOUS RESEARCH FOR LONGER THAN A 5-YEAR PERIOD. THESE CAN BE UP TO 10 YEARS SUPPORT. HOWEVER, THEY COME IN AS RO1 AND COMES IN AS RO1 AND BASED ON THE RESEARCH PROJECT OBVIOUSLY WITH CREDENTIALS OF INVESTIGATOR GOING WITH IT FOCUS IS ON THE RESEARCH PROJECT. IT IS A NOMINATION THAT IS DONE BY STAFF ESSENTIALLY AND COMES TO COUNCIL FOR CONCURRENCE ABOUT THOSE THAT WILL RECEIVE MERIT AWARDS TO EXTEND RESEARCH FOR UP TO 10 YEARS. SO THIS IS A TABLE THAT WE PUT TOGETHER. I WANT TO SHOUT OUT TO DENIS TWABLY AND MJ FOR PUTTING THE INFORMATION TOGETHER IN PUTTING INFORMATION ACROSS INSTITUTES. THIS IS RESEARCH USING N35 AS TOOL TO SUPPORT RESEARCH. YOU WILL SEE TWO THAT I MENTIONED MIGIS AND NCI. IN ADDITION WE HAVE HEART LUNG AND BLOOD INSTITUTE AND NEUROLOGY INSTITUTE AND ENVIRONMENTAL HEALTH AND DENTAL CRANIAL FACIAL RESEARCH INSTITUTE. IMPORTANT AS -- BECAUSE THIS IS A FEATURE THAT IS VERY IMPORTANT FOR THE R35 PROGRAM, IF IN TERMS OF ELIGIBILITY, WHILE THERE ARE SOME SHADES OF DIFFERENCE ACROSS INSTITUTES, THE PRIMARY THING IS THAT YOU ARE LOOKING AT THE HISTORY OF ONES RO1 SUPPORT. ALL RIGHT? IT DOESN'T MATTER IN TERMS OF OTHER RESEARCH GRANT OR PROGRAM PROJECT OR CENTER GRANTS OR ANYTHING LIKE THAT. IT IS FOCUSED ON R01. IT CAN BE IN TERMS OF LONGEVITY OF SUPPORT IN SOME CASES OR NUMBER OF RO ONES THAT ONE HAS. FOR EXAMPLE GM HAS IT TO BE ELIGIBLE YOU HAVE TO HAVE TWO CONCURRENTLY FUNDED NRGMS RO ONES OR ONE THAT THEY CONSIDER TO BE LARGE RO100 THAT IS OVER $400,000. THAT IS ELIGIBILITY REQUIREMENTS FOR IT. SOME HAVE VARIATIONS WITH REGARD TO THAT. THE BUDGET FOR THE R35 VARIES. BASICALLY, IT IS RUNNING FROM AROUND 600 TO 750,000. THAT IS THE DIRECT COST TO THE INVESTIGATOR. IT DOESN'T INCLUDE THE INSTITUTIONAL COSTS ON TOP OF IT. IT IS NOT TOTAL COST PER YEAR. AGAIN, THE LENGTH OF TIME THAT WE ARE TALKING ABOUT, IT VARIES ACROSS THE INSTITUTES FROM FIVE YEARS TO EIGHT YEARS. SOMETHING THAT THE INSTITUTES GET TO DECIDE ESSENTIALLY IN TERMS OF HOW LONG THEY WILL DO THIS. THE OTHER FEATURE OF AN R35 THAT FOR MOST OF THE OTHER INSTITUTES EXCEPT FOR OUR VERY LARGE INSTITUTES, IT IS THAT WHEN AN INVESTIGATOR ACCEPTS THE R35, THEY ALSO THEREFORE RELINQUISH OTHER RESEARCH GRANTS THEY HAVE WITH THAT INSTITUTE. IDEA IS THAT THEY ARE CONSOLIDATING THEIR WORK INTO THIS ONE AWARD. SO THAT IS BASICALLY THE PHILOSOPHY BEHIND ALL OF THIS. WITH REGARD TO WHERE WE ARE RIGHT NOW IN TERMS OF NUMBERS OF WHAT WE HAVE HERE, CUMULATIVE NUMBER OF AWARDS ISSUED BY INSTITUTES YOU SEE MIGS IS AHEAD OF THE PACK IN TERMS OF ISSUING R35 AND IT GOES ALL THE WAY DOWN TO DENTAL INSTITUTE THAT CURRENTLY HAS NINE OF THE AWARDS AND COMMENSURATE WITH THAT OF COURSE IS AMOUNT OF FUNDS THAT HAVE BEEN DEVOTED TO THAT. LAST THING I WANTED TO DRAW TO YOUR ATTENTION ON THIS IS IT IS A VERY DETAILED SLIDE IS THE LITTLE ASTERISK. ONE QUESTION I HAD WAS WHETHER OR NOT THOSE INSTITUTES THAT OFFER THE R35 WERE ALSO OFFERING R37 WHICH IS THE MERIT AWARD. AT LEAST IN TERMS OF THE DOCUMENTATION, IT APPEARS CANCER NEUROLOGY, ENVIRONMENTAL HEALTH NIDCR ARE ALL STILL OFFERING MERIT AWARD. WHEN WE LOOKED QUICKLY AT SYSTEM LAST NIGHT BEFORE IT SHUT DOWN ON US, YES. ONE OF THE FUN THINGS. WE FOUND THAT IN TERMS OF ACTIVE AWARDS RIGHT NOW, IT IS JUST THE CANCER INSTITUTE, NEUROLOGY, AND THIS INSTITUTE IN TERMS OF ONES THAT WE ARE TALKING ABOUT THAT CURRENTLY HAVE THE MERIT AWARDS. OTHER INSTITUTES AT LEAST CURRENTLY DON'T SEEM TO HAVE ANY ON THE BOOKS. DOESN'T MEAN THEY WON'T BUT THEY CURRENTLY DON'T. WE THOUGHT TOO IN TERMS OF OUR PROGRAM WE CURRENTLY OFFER IN TERMS OF EXTENDING RESEARCH AND TIME, IT WOULD BE INTERESTING TO KNOW ARE WE MEETING THE GOALS ESSENTIALLY OF THE PROGRAM IS IT HIGHLY MERITORIOUS RESEARCH BEING FUNDED THROUGH R37? THERE IS A NUMBER OF WAYS ONE COULD ADDRESS THAT QUESTION. ONE THAT WAS RELATIVELY EASY FOR US TO DO WAS TO LOOK AT THE RELATIVE CITATION RAISHIO FOR A GROUP OF OUR RO ONES COMPARED TO R37S. YOU WILL SEE, FIRST OF ALL, THE GOOD NEWS, THE REALLY GOOD NEWS IS IN OUR R01 POOL, THE MEDIAN, OKAY THE DARK BLUE LINE IS ABOVE 1 WHICH IS IMPORTANT. 1 IS STANDARD FOR NIH OF RELATIVE CITATION RATIO. BEING ABOVE ONE IS NOT LIKE YOU ARE ABOVE 1 YOU ARE REALLY ABOVE 1. YOU CAN SEE -- AGAIN, THIS IS A BOX AND WHISKERS THIS IS 75% QUARTILE AND THIS IS 75TH QUARTILE. MERIT AWARDS ARE RUNNING HIGHER THAN R0 ONES WHICH ARE AROUND 1.3. MEDIAN AND THIS IS AROUND 1.5 FOR MERIT AWARD. IT DOES APPEAR THAT OUR MERIT PROGRAM IF YOU LOOK AT THIS AS AN INDEX IS ACTUALLY ACCOMPLISHING ONE OF ITS GOALS WHICH IS TO SUPPORT HIGHLY MERITORIOUS RESEARCH. OKAY. SO ONE OF THE OTHER QUESTIONS I THINK THAT IS RELEVANT FOR BOTH MERIT PROGRAM AS WELL AS R35 PROGRAM IS WHAT KINDS OF SCIENCE ESSENTIALLY ARE WE TALKING ABOUT THAT IS EITHER APPLYING FOR OR BEING NOMINATED FOR THESE TYPES OF AWARDS. I WILL DRAW OUR ATTENTION FIRST TO THE LEFT PART, THESE TWO BOXES. THIS PERTAINS SPECIFICALLY TO NICHD. THE FIRST AREA I WANT YOU TO LOOK AT HERE IS R01 DISTRIBUTION HERE. WHAT WE HAVE HERE IS PERCENTAGE OF R0 ONES THAT INVOLVE HUMAN SUBJECTS AND PERCENTAGE THAT DO NOT. THIS IS ONE ROUGH AND ONE COULD ARGUE CRUDE IN EXTENT OF CLINICAL VERSUS NONCLINICAL RESEARCH. YOU SEE NICHD WE ARE HEAVY AND TILTED TO R01 POOL WITH RESEARCH HUMANS AND CLINICAL RESEARCH IN COMPARISON TO 32% THAT DOESN'T INVOLVE HUMANS. ALL RIGHT? IN TERMS OF R37S, DISTRIBUTION IS A LITTLE BIT TILTED, ESSENTIALLY, MORE TO THE NON-HUMAN WORK. 55% OF R37S FOCUSED ON NON-HUMAN WORK VERSUS 45%. THERE IS A TENDENCY ALREADY FOR NON-HUMAN WORK TO BE PART OF OUR MERIT PROGRAM. LOOKING NOW AT THE R35, I WILL GO TO THE OTHER INSTITUTES NOT NICHD. IN TERMS OF DISTRIBUTION OF THEIR R0 ONES, YOU SEE A HEAVY COMMITMENT TO THE NONCLINICAL IN THE OTHER INSTITUTES. ALMOST THE FLIP OF WHAT WE HAVE HERE AT NICHD. THIS IS NOT -- IN CASE SOMEONE ASKS ME NO. THIS IS NOT SURPRISING TO ME. WE LOOKED AT THIS DATA ABOUT THREE OR FOUR YEARS AGO. MIKE LOWER AT NIH AND DEPUTY RESEARCH DIRECTOR RAN DATA FOR US. HE DIDN'T BELIEVE IT AT FIRST. HE DOUBLE CHECKED IT AND WAS LIKE, NO. YOUR INSTITUTE IS PRETTY MUCH THE OPPOSITE OF MANY OF THE OTHER INSTITUTES IN TERMS OF OUR DISTRIBUTION. YOU WILL SEE, THEN, FOR -- NOT SURPRISINGLY THEN FOR R35S THAT, THAT DISTRIBUTION IS MAINTAINED AND INDEED SLIGHTLY EXAGGERATED WITH R35S FALLING INTO NORN HUMAN WORK. THAT IS IMPORTANT TO TAKE INTO THE CONTEXT ABOUT THE SCIENCE ESSENTIALLY THAT IS BEING SUPPORTED THROUGH THE DIFFERENT TOOLS. OKAY. SO THE LAST THING I WANTED TO DRAW ON AND THIS IS A VERY -- IT IS A SLIDE THANK YOU TO ALEXIS AND MELANIE LADEW WHO HELPED PUT THIS TOGETHER AS YOU REBEL JIBLT CRITERIA VARIES ACROSS R35 THEY RESTRICT TO INDIVIDUALS WITH TWO AWARDS OR MORE. WE WANTED TO HAVE AN IDEA WHAT KIND OF SAMPLING AND WHAT ARE WE TALKING ABOUT HERE IN TERMS OF NUMBERS? SOME OF INSTITUTES IT IS ONLY ONE AWARD. IT IS ONE R1 AWARD BUT LONGEVITY COMPONENT TO IT. WE DON'T HAVE LONGEVITY COMPONENT HERE BUT IN TERMS OF NUMBER OF PEOPLE. THIS IS THE NUMBER OF PEOPLE AND NUMBER OF INVESTIGATORS. THIS IS NOT THE NUMBER OF AWARDS BUT NUMBER OF INVESTIGATORS WITH ONE AWARD FOR US. YOU WILL SEE THAT IS THE LION SHARE AND IT DROPS PRETTY DRAMATICALLY TO TWO OR MORE AWARDS. DEPENDING ON HOW ONE USES R35, YOU WOULD HAVE A VERY -- POTENTIALLY A VERY HUGE DIFFERENCE IN TERMS OF ELIGIBILITY OF FOR THE PROGRAM AT THIS INSTITUTE. OKAY. IT THAT WAS SORT OF THE BRIEF OVERVIEW IN TERMS OF PROVIDING, AGAIN, WHAT OTHER INSTITUTES ARE DOING WITH REGARDS TO THIS TO THE BEST OF MY KNOWLEDGE. 6 INSTITUTES CURRENTLY USING R35 SEEM TO BE PLEASED WITH THAT MECHANISM. I HAVE NOT HEARD THAT THEY WILL CHANGE NOR HAVE I HEARD THAT ANY OTHERS WERE GOING TO JOIN. SO -- AND HOPEFULLY THAT PROVIDED SOME PERSPECTIVES. I OPEN IT FOR QUESTIONS AND COMMENTS. YES? >> CLIFF TAIBEN. I BELIEVE MY COMMENTS WERE AMONG THOSE THAT PROMPTED THIS DISCUSSION. I'M A BIG FAN OF THIS MECHANISM. I THINK IT GIVES THE OPPORTUNITY SO THAT THE NUMBER OF GRANTS THAT PEOPLE HAVE TO SUBMIT TO GET FUNDED ESPECIALLY IF YOU HAVE TWO OR THREE GETS VERY BURDENSOME. FOR SOME REALLY TOP INVESTIGATORS PEOPLE WHO ARE VERY VERY PRODUCTIVE AND CARRYING TWO OR THREE R0 ONES SUBMIT GRANTS ALMOST EVERY CYCLE WHEN THEY GET CLOSE TO RENEWALS IT IS NOT ONLY A BURDEN ON THEM BUT STUDY SECTIONS THAT ARE GETTING THESE MANY, MANY APPLICATIONS; RIGHT? SO THE MAIN THING ABOUT THIS APPROACH, TO ME, IS THE CONSOLIDATION. THERE IS NO REASON IT SHOULD COST INSTITUTE MONEY OR TAKE MONEY AWAY FROM OTHER PROGRAMS IF YOU TRUST THE SYSTEM TO ONLY GIVE AWARDS TO PEOPLE WHO PROBABLY HAVE MAINTAINED MULTIPLE GRANTS FOR A LONG TIME ANYWAY AND YOU MAKE THEM TURN BACK R0 ONES THEY HAVE IN MOST CASES IF YOU HAVE 2 OR 3R0 ONES ESPECIALLY 3R0 ONES YOU ACCEPT LESS MONEY TOTAL THAN YOU HAD BEFORE IN A SENSE. GIVES YOU NO. 1 THAT LONG TERM SUPPORT WITH ONLY A SINGLE APPLICATION AND NO. 2 FLEXIBILITY TO PURSUE RESEARCH AND TAKING THE SUBSET OF INVESTIGATORS WHO ARE REALLY AT THE TOP OF THE GROUP AND DOING FUNDAMENTAL RESEARCH TO BE ABLE TO HAVE A LITTLE MORE FLEXIBILITY IN THE DIRECTIONS THAT THEY GO OVER TIME. SO I WOULD BE VERY MUCH IN FAVOR OF AT LEAST RECONSIDERING THE POSSIBILITY OF STARTING IT WITHIN OUR INSTITUTE. I THINK IT IS A VALUABLE MECHANISM THAT NEED NOT TAKE MONEY AWAY FROM OTHER INDIVIDUALS IF IT IS SET UP CORRECT THELY AND CAN REALLY SUPPORT THE HIGHEST SCIENCE AND FREE PEOPLE UP BOTH FROM THE BURDEN IN TERMS OF WRITING AND HAVING TO EVALUATE MANY, MANY GRANT APPLICATIONS. >> DELLA HANN: ANY OTHER COMMENTS? YES. >> INTERESTED IN [INDISCERNIBLE] EARLY STAGE INVESTIGATOR R01. DO THEY HAVE I GUESS THE INTENTIONAL AIM THEN TO GIVE THESE KINDS OF AWARDS TO WHAT MIGHT BE MORE MID-LEVEL INVESTIGATORS OR AT LEAST KRON LOGICALLY YOUNGER IN SOME SENSE COMPARED TO THE OTHER INSTITUTES? I JUST DIDN'T UNDERSTAND ABOUT THAT. >> DELLA HANN: RIGHT. SO SOME OF THE INSTITUTES ACTUALLY HAVE A RUN -- RUN A CONCURRENT PROGRAM DEVOTED MORE TO THE NEWER INVESTIGATORS. THEY GENERALLY DON'T DO THE MIX LIKE THAT. THIS IS A SHORT HAND WE USED ON THE SLIDES. IT IS NOT AN AND BUT AN OR KIND OF THING AND GENERALLY WHEN THEY TALK ABOUT NEWER STAGE INVESTIGATORS THIS HE DROP THE DOLLAR AMOUNT. IT WON'T BE 600 TO 800 BUT IT WILL BE LOWER FIGURE FOR THE NEW ONES. THAT WAS ONE OF THE COMMENTS THAT WAS RAISED EARLY ON IN THE DEVELOPMENT OF THE PROGRAM WHICH WAS AS IT WAS FIRST FORMLELATED IT VERY MUCH WAS LOOKING AT PEOPLE WHO HAD A TRACK HISTORY. THEY WERE LIKE -- THEN WE ALSO HAVE THE NEED ESSENTIALLY TO MAKE SURE OUR NEWER INVESTIGATORS HAVE VARIOUS OPPORTUNITIES. SOME INSTITUTES DEVELOP TRACKS IF YOU WILL FOR NEWER INVESTIGATORS. OKAY. DO I HAVE ANY ENTHUSIASM FROM THE GROUP WITH REGARD TO SETTING UP SUB-COMMITTEE OF COUNCIL TO FURTHER INQUIRE AND LOOK AT THIS PARTICULAR ISSUE? I SEE A COUPLE OF HEADS NODDING. IF THAT IS THE CASE, I'M LOOKING FOR THE VOLUNTEERS TO BE PART OF THAT. OKAY? SO WE HAVE TONY. WE HAVE CATHERINE AND CLIFF. AM I MISSING ANYBODY? AND MICHAEL. >> I WOULD PROPOSE THAT CLIFF CHAIR THE GROUP. HE ORIGINALLY BROUGHT IT UP AND HE CLEARLY HAS A PASSION FOR THIS AREA. I THINK HE WILL DO A GREAT JOB. SO -- >> DELLA HANN: GREAT. ALL RIGHTY. THANK YOU. I WILL ZOOM AHEAD HERE. OKAY. VERY QUICKLY, I WANTED TO PROVIDE YOU WITH SOME STAFFING UPDATES THAT HAPPENED HERE IN THE EXTRAMURAL PROGRAM. WE TRY TO DO THIS EVERY TIME. THIS -- SINCE WE MET IN JANUARY, WE HAVE HAD TO SAY A VERY FOND FAREWELL TO FOUR MEMBERS OF THE EXTRAMURAL STAFF. THE FIRST DR. PINKY CHATTER JI. OKAY. SHE HAD BEEN WORKING IN OUR SCIENTIFIC REVIEW BRANCH AND SHE HAS A BACKGROUND IN DEMOGRAPHY AND ACCEPTED AN EXCITING NEW POSITION AT NIDA DRUG AINSTITUTE TO WORK ON BCB BRAIN PROJECT IN PROGRAM. TE SECOND TRANSITION WAS DR. ROSE HIGGINS MANY ON THE COUNCIL WERE FAMILIAR WITH ROSE WHO WAS A PROMINENT MEMBER OF PERI-NATOLOGY AND PREGNANCY BRANCH AND INFORMATIVE IN NEONATAL RESEARCH ROSE IS CURRENTLY SERVING NOW AS ASSOCIATE DEAN FOR RESEARCH AT GEORGE MASON UNIVERSITY. WE WISH HER REALLY ALL THE VERY BEST WHICH IS A GREAT, GREAT POSITION. SHE IS A TRUE LOSS NOT ONLY FOR NICHD BUT ALL FEDERAL GOVERNMENTS AND SHE IS NO LONGER APART OF IT WE WISH HER THE VERY BEST THIRD IS MERE DIJ TEM M O-CONNOR SHE WAS SERVING AS CLINICAL RESEARCH OFFICER AND WAS INCREDIBLY INFORMATIVE IN HELPING THE INSTITUTE TO SHAPE POLICIES AND PROCEDURES WITH ALL OF THE NEW MANDATES FOR CLINICAL TRIAL MONITORING THAT WAS COMING FROM THE CENTRAL NIH. MER DIJ TOO LEFT TO TAKE EXCITING NEW POSITION AT DIRECTOR OF SCIENCE POLICY AT NCATS INSTITUTE. 4TH AND CERTAINLY NOT LEAST IS DR. KATERINA SILU TSILOU WHO HAD BEEN IN OBSTET TRICKS AND PERI-NATOLOGY RESEARCH BRANCH IN TERMS OF FARMLECY -- EXCUSE ME. I TOTALLY BOTCHED IT THAT OBSTET TRICKS AND PEDIATRIC PHARMACOLOGY AND THERAPEUTICS BRANCH KATERINA HAD BEEN WITH US A NUMBER OF YEARS MEDICAL ORIGINAL TRAINING WAS IN OPT THOMOLOGY AND HEARD THE CALL TO GET BACK TO HER CLOSER SCIENTIFIC ROOTS AND JOINED FDA AND WILL WORK WITH THEM IN THAT PARTICULAR AREA OF SCIENCE. WE WISH THEM THE VERY BEST. IN ADDITION, WE ALSO ADDED SOME FOLKS. SOME LEAVE AND SOME COME BACK IN. WE HAVE THREE FOLKS WHO HAVE RECENTLY JOINED THE INSTITUTE. VICKY HAINS. I DON'T KNOW IF SHE IS IN THE ROOM OR NOT GRANTS MANAGEMENT BRANCH. SHE HAS A STRONG HISTORY OF GRANTS MANAGEMENT WORKING AT COUPLE OTHER INSTITUTES RECENTLY AT NEUROLOGY INSTITUTE AND WAS INFORMATIVE OF GRANTS MANAGEMENT RESPONSIBILITIES WITH REGARDS TO CLINICAL TRIALS. SHE IS A GREAT ADDITION ESSENTIALLY TO NICHD AND DR. CLAI MASH WHO IS JOINING US IN THE INTRAMURAL PROGRAM HERE AT NICHD SERVING AS A PSYCHOLOGY WITH FOCUS ON EARLY CHILD DEVELOPMENT AND COGNITION. IS HE JOINING US AND WILL WORK AS A PROGRAM ANALYST IN THE NATIONAL CENTER FOR MEDICAL REHABILITATIVE RESEARCH CENTER. THIRD, DR. RON AH POPKIN RONNAPOPKIN. RECEIVED PHD FROM COLUMBIA UNIVERSITY JOINING US AS PROGRAM OFFICIAL AND WORKING IN POPULATION DYNAMICS BRANCH. WE ARE DELIGHTED TO HAVE ALL THREE OF THEM BE NEW MEMBERS FOR NICHD EXTRAMURAL NEW MEMBERS. AS DIANA INDICATED, WE CONTINUE TO HIRE AND WE HAVE SEVERAL BRANCH CHIEF POSITIONS THAT ARE STILL AVAILABLE AS WELL AS A NUMBER OF PROGRAM BOTH MEDICAL OFFICERS AND HEALTH SCIENCE ADMINISTRATOR POSITIONS THAT ARE OPENED IN A VARIETY OF THE BRANCHES. THIS IS A TREMENDOUSLY GREAT TIME TO COME ON BOARD ESSENTIALLY AS WE LAUNCH THE IMPLEMENTATION OF THE STRATEGIC PLAN AND IT IS VERY EXCITING IN TERMS OF REFRESHMENT AND GETTING EVERYONE'S CREATIVITY BACK IN GEAR AGAIN. I'M HOPEFUL THAT IF YOU KNOW OF INDIVIDUALS WHO MAY BE LOOKING FOR SOMETHING A LITTLE DIFFERENT THAN TO STEER THEM OUR WAY. THE ROLE -- THERE WAS A RECENT ARTICLE PUBLISHED BY FORMER STAFF MEMBER DR. TONSARAJAU IF IN PEDIATRICS RESEARCH. IT IS A SHORT OVERVIEW OF HIS WORK AT NICHD AND GREAT THINGS THAT HE PERSONALLY WAS ABLE TO ACCOMPLISH AND DESCRIBING ESSENTIALLY WHAT IT IS LIKE TO BE A MEMBER OF THE PROGRAM STAFF IN TERMS OF REALLY BEING INFORMATIVE IN SHAPING RESEARCH AND TRAJECTORIES OF RESEARCH FOR MANY YEARS. I WOULD HOPE THAT IF YOU -- IF YOU ARE INTERESTED IN THE ARTICLE, I WOULD BE HAPPY TO SEND IT TO YOU. INCLUDING IT IN RECRUITMENT MATERIALS, ESSENTIALLY. DIFFICULT TO TRULY UNDERSTAND THE ROLES THAT WE PLAY HERE. THEY ARE NOT TRADITIONAL ACADEMIC OR MEDICAL POSITIONS. THEY ARE UNIQUE. I ENCOURAGE EVERYONE TO HELP US IN TERMS OF GETTING THE WORD OUT TO WONDERFUL FOLKS AND THANK YOU. >> DIANA BIANCHI: THANK YOU DELLA. WE WILL ASK THAT YOU PROVIDE BRIEF OVERVIEW OF 20 NEENTAIN STATEMENT OF UNDERSTANDING. AS YOU WALK OVER HERE WE SHOULD SEND TONSLA ARTICLE TO MEMBERS HERE HE TALKED ABOUT PERSONAL EXPERIENCES HERE AND TABLE IN THE ARTICLE THAT REALLY TALKED ABOUT THE WAYS THAT HIS WORK WAS ABLE TO HAVE AN IMPACT. IT IS REALLY -- I -- I THINK IT IS A GREAT OPPORTUNITY FOR RECRUITMENT. SO PEOPLE WOULD UNDERSTAND BETTER WHAT IS IT THAT PROGRAM OFFICER OR SCIENTIST DOES ON A DAILY BASIS. >> DELLA HANN: OKAY. WE WILL DO THAT AND BE SURE TO SEND THAT OUT TO EVERYONE. I WOULD LIKE TO TURN TO THE STATEMENT OF UNDERSTANDING WHICH I BELIEVE THAT ALL OF YOU HAVE OR WERE ABLE TO READ OFF OF THE WEBSITE. DRAFT STATEMENT OF UNDERSTANDING BETWEEN NICHD AND ADVISORY COUNCIL AS I SAID WAS POSTED ON COUNCILMEMBER'S WEBSITE. IT PROVIDES A VERY SHORT BUT HOPEFULLY CONCISE SYNOPSIS OF ACTIVITIES OF COUNCIL MEMBERSHIP AND STRUCTURE AND SECOND LEVEL OF REVIEW GRANT APPLICATIONS AND CONCEPT REVIEW. SO I CAN SEE SOME HEADS NODDING THAT FOLKS WERE ABLE TO TAKE A LOOK AT IT. IF I CAN HAVE A MOTION THAT YOU WOULD LIKE TO TAKE WITH REGARD TO THAT STATEMENT? MONTH OF TO PASS. SECOND? >> SECOND. >> DELA HANN: THOSE IN FAVOR? OKAY. I DON'T SEE -- OKAY. WELL, OKAY. THOSE NO THE IN FAVOR ABSTENTIONS? GREAT. THANK YOU VERY MUCH. BACK TO DR. BIANCHI. >> DIANA BIANCHI: GREAT. SO FOR THOSE OF YOU NEW TO COUNCIL, EXCUSE ME. I JUST WANT TO EXPLAIN THAT OUR STRATEGIC PLANNING PROCESS HAS NOW BEEN GOING ON FOR A YEAR AND A HALF. IT STARTED WITH ADVICE FROM OUR ADVISORY COUNCIL. YOU WERE THE FIRST TO HEAR WHAT IT IS THAT WE NEEDED TO DO AND YOU SET US ON THE PATH. WE ARE VERY GRATEFUL FOR THAT. WHAT WE ARE PLANNING TO DO IS GIVE YOU AN UPDATE. AS YOU KNOW, WE HAVE BEEN VERY TRANSPARENT ALL ALONG WITH THE ADVISORY COUNCIL AND PEOPLE LISTENING IN GREATER CYBER SPACE. THIS WILL BE IN TWO PARTS. FIRST, I WILL SHARE WITH YOU OUR RESPONSE TO STAKEHOLDER FEEDBACK. THEN WE WILL HAVE A DISCUSSION ABOUT OUR PROPOSED REFRESHED MISSION AND VISION STATEMENTS. SO THE GOALS HAVE NOT CHANGED FROM THE VERY BEGINNING. AND, AGAIN, IT IS TIME FOR A NEW STRATEGIC PLAN. WE HAVEN'T HAD ONE SINCE THE YEAR 2000. SO THE GOALS ARE TO IDENTIFY WHERE NICHD SHOULD LEAD. IN OTHER WORDS, WE CAN'T FUND EVERYTHING. CURRENTLY, WHEN YOU LOOK AT OUR PORTFOLIO, WE ARE VERY BROAD AND IN SOME AREAS WE ONLY HAVE ONE OR TWO R0 ONES. QUESTION IS DO WE WANT TO DO THAT OR INVEST HEAVILY IN CERTAIN AREAS AND REALLY MAKE A DIFFERENCE. REMEMBER WE HAVE $1.5 BILLION BUDGET WHICH IS A LOT OF MONEY. WE HAVE TO IDENTIFY WHAT ARE OUR PRIORITIES BOTH PUBLIC HEALTH AS WELL AS SCIENTIFIC PRIORITIES. 27 INSTITUTES AND CENTERS AT NIH. THERE IS OVERLAP. FOR EXAMPLE, AGAIN, FOR NEW PEOPLE, WE DON'T FUND ALL OF CHILD HEALTH RESEARCH JUST 18% OF CHILD/HEALTH RESEARCH. FOR THINGS THAT SPECIFICALLY RELATE TO CHILDREN AND CHILD HEALTH WE CAN PARTNER AND COLLABORATE AND HAVE MECHANISM FOR THAT THROUGH NIH TRANCE PEED YA THE TRICK METRICS CONSORT SHUM AND WE WILL TRANSFORM FUTURE INVESTMENTS IN RESEARCH TRAINING AND INFRASTRUCTURE SO YOU WILL BEGIN TO SEE SOME SHIFTING OF RESOURCES RELATED TO SCIENTIFIC PRIORITIES ONCE WE FINALIZE THE STRATEGIC PLAN. ALL ALONG, OUR CORE PRINCIPALS HAVE BEEN TRANSPARENCY AND DECISIONS INFORMED BY EVIDENCE AND COUNCIL HAS HEARD VERY EXTENSIVE ANALYSIS OF OUR PORTFOLIO WHERE WE CURRENTLY SPEND AND WHERE OTHER PARTS OF THE OTHER INSTITUTION ALSO SPENDS AND WHERE IMPACT AS A RESULT OF MONEY THAT WE HAVE SPENT AND OTHER PRINCIPLE IS STAKEHOLDER PARTICIPATION WHICH IS WHERE WE WILL FOCUS TODAY. TOO MANY BUTTONS HERE. SO ANY BELIEVE IT WAS JANUARY 2ND, WE MADE PUBLIC A REQUEST FOR INFORMATION. SO BY THE END OF DECEMBER, WE HAD A FRAMEWORK FOR THE STRATEGIC PLAN. IT WAS NOT FINAL. IT WAS A DRAFT. IT WAS SOMETHING TO EVOKE REACTION AND REACTIONS WE GOT. WE WERE VERY HAPPY WE GOT ALMOST 1,000 TOTAL COMMENTS TO THE DRAFT PLAN. THE COMMENTS TOUCHED ON MULTIPLE THEMES AND SCIENTIFIC AREAS. WE HAVE NOW MADE AVAILABLE TO YOU. YOU CAN READ THE SUMMARY REPORT, WHICH NOT ONLY GIVES THE ORIGINAL FRAMEWORK, BUT ALSO BY TOPIC, BY THE TOPICS IN THAT DRAFT FRAMEWORK, SUMMARIZES THE COMMENTS THAT WERE RECEIVED. I WOULD LIKE TO THANK ALL OF THE PEOPLE WHO COLLECTED THE COMMENTS AND READ THEM AND GROUPED THEM AND ENSURED THAT, YOU KNOW, THERE WERE MANY TOPICS OR COMMENTS FOR EXAMPLE ON TOPIC OF SUDDEN INFANT DEATHS YOU DON'T SEE 400 TOPICS ON THAT. THEY ARE ALL GROUPED. IT IS VERY READABLE. THESE WERE THE ORIGINAL THEMES. THESE ARE NOT WHAT THE ULTIMATE THEMES ARE GOING TO BE. IT IS STILL UNDER CONSTRUCTION. THIS IS WHAT THE COUNCIL HEARD PREVIOUSLY. THEME 1 UNDERSTANDING EARLY HUMAN DEVELOPMENT THEME 2 SETTING FOUNDATION FOR HEALTHY PREGNANCY AND LIFE-LONG WELLNESS THEME 3 PROMOTING GYNECOLOGICAL AND REPRODUCTIVE HEALTH. THEME 4 -- THEME 5 IMPROVING HEALTH DURING TRANSITION FROM ADOLESCENCE TO ADULTHOOD AND THEME 6 SAFE AND THERAPEUTIC DEVICES FOR OUR POPULATIONS UNDER CONSTRUCTION. NOT THE FINAL. SO THIS IS WHERE WE ARE THANKS TO OUR STAKEHOLDER PARTICIPATION. WE HAVE INCORPORATED A LOT OF INPUT. RFI IS ONE PART OF THAT. IT IS 924 COMMENTS. WE ALSO INCLUDED SMALL WORKING GROUPS FROM ACROSS THE INSTITUTE, INCLUDING BOTH PROGRAM STAFF FROM THE DIVISION OF EXTRAMURAL RESEARCH AND MANY OF THE PEOPLE IN THIS ROOM. I WANT TO THANK YOU ALL FOR YOUR TIME AND EFFORT. I KNOW THERE WERE FOUR-HOUR MEETINGS IT THAT WERE ENDLESS. THEY PROVIDED US WITH LOTS OF IMPORTANT FEEDBACK. COUNCIL, AS I ALREADY MENTIONED, GAVE US IMPORTANT INFORMATION. WE HELD A WORKING GROUP MEETING IN OCTOBER OF 2018. THIS WAS ALL KIND OF SHAKE ENUP. I LIKE THE KIND OF MARTINI GRAPHIC HERE. IT WAS ALL SHAKE ENUP AND STIRRED AND CAME OUT WITH A REVISED STRATEGIC PLAN. SO THE REVISIONS REPRESENT THE SYNTHESIS FROM ALL OF THESE SOURCES. WE WON'T TALK ABOUT THE FINAL VERSION TODAY. IT IS NOT FINAL. IT IS STILL BEING WORKED ON. WHAT I WILL SHARE WITH YOU TODAY ARE SOME DIRECT -- YOU KNOW, HOW WE RESPONDED TO THE COMMENTS AND REVISIONS TO EXPECT IN THE FINAL PLAN. NOW, ONE THING THAT WE REALIZED WAS THAT WE DIDN'T ARTICULATE WELL ENOUGH IN THE DRAFT FRAMEWORK THAT -- THAT THERE WOULD BE CROSS-CUTTING THMES. WE CAME UP WITH A CONCEPT OF THE WARP AND WEFT. WHERE WARP WOULD BE MAJOR SCIENTIFIC AND PUBLIC HEALTH PRIORITIES IN TERMS OF THEMES AND WEFTING WOULD [AUDIO LOST] >> WELL, I REMEMBER, CLIFF, YOU HAD CONCERNS ABOUT DEVELOPMENTAL BIOLOGY AND ANIMAL MODELS. WE HAVE NOW AN INCREASED EMPHASIS ON A VARIETY OF MODEL SYSTEMS TO UNDERSTAND TYPICAL DEVELOPMENTAL PROCESSES. THIS IS OUR BEAUTIFUL ZEBRA-FISH FACILITY. I KNOW WHEN I WAS ON COUNCIL VISITING THE ZEBRA-FISH FACILITY WAS A MEMORABLE EXPERIENCE OF MY COUNCIL WE MIGHT WANT TO REMEMBER THAT FOR SEPTEMBER AS A FIELD TRIP ON CAMPUS. WE HAVE EXPANDED AND ANOTHER CONCERN WAS SECTION ON EARLY HUMAN DEVELOP WAS TO FOCUS ON SINGLE-CELL BIOLOGY. WE ARE INCLUDING A BROADER VIEW OF GENES AND GENE REGULATORY NETWORKS AND HOW THEY CONTRIBUTE TO STRUCTURAL ABNORMALITIES. WHAT I TOOK AWAY FROM LAST COUNCIL MEETING IN JANUARY IS WE HADN'T ARTICULATED WELL NUR STRONG INSTITUTIONAL COMMITMENT TO INSTITUTIONAL AND DEVELOPMENTAL DISABILITIES IT IS CLEARLY ARTICULATED WE WILL HAVE A FOCUS ON TYPICAL AND ATYPICAL NEURODEVELOPMENT FROM EARLIEST DEVELOPMENTAL STAGES. WE ARE ALSO MAKING SURE THAT WE ARE INCORPORATING INDIVIDUALS WITH INTELLECTUAL AND DEVELOPMENTAL DISABILITIES THROUGHOUT THE PLAN FROM EARLY HUMAN DEVELOPMENT TO THE TRANSITION TO ADULTHOOD AND ADULT CARE AND INCLUSION AND DEVELOPMENT OF TESTING OF THERAPEUTICS AND DEVICES FOR THIS SPECIFIC POPULATION. IN REPRODUCTIVE HEALTH, WE INTENDED BUT PERHAPS IT WASN'T PERCEIVED AS SUCH THAT WE -- ONE OF THE REASONS WHY WE ARE INCLUDING REPRODUCTIVE HEALTH IS WE REALLY SEE IT AS PART OF THE CONTINUUM OF FUTURE HEALTH WHICH IS BOTH DEVELOPMENTAL ORIGINS OF HEALTH AND DISEASE AS WELL AS TRYING TO EMPHASIZE THE IMPORTANCE OF PRECONCEPTION AS WELL AS PREGNANCY ON AN INDIVIDUAL'S LIFELONG HEALTH. WE ADDED INVESTIGATION OF DEVELOPMENTAL PROCESSES THAT RESULT IN ABNORMALITIES OF FEMALE AND MALE REPRODUCTIVE TRACKS WE SEPARATED IT OUT FROM EARLY HUMAN DEVELOPMENT AND PUT IT NOW WITH THE REPRODUCTIVE THEMES. WE ALSO CLARIFIED THE NEED FOR BETTER CHARACTERIZATION AND DEFINITION OF GYN COLOJIC AND AND/OR LOGIC CONDITIONS AND RETAINED EM FASIUS ON FERTILITY AND INFERTILITY WITH SPECIFIC METHODS TO ROLES OF -- THIS IS WITH RESPONSE TO COMMENTS WE RECEIVED AND REGARDS TO HEALTHY -- PREPREGNANCY FACTORS WE INCORPORATE AND MAKE CLEAR FOR WHERE THAT ARE WORRIED ABOUT WHERE IS THE PLACENTA. WE ARE REEMPHASIZING PRIORITY ON PLACENTAL BIOLOGY AND PLACENTAL CLINICAL RESEARCH. AS I SAID BEFORE, PLACENTA IS OUR ORGAN. WE ARE ALSO SPECIFICALLY DELINEATING THE 4TH TRIMEFTER THAT IS IMPORTANT WITH REGARDS TO MATERNAL MORTALITY AND LONG TERM FOLLOW UP WITH CONSEQUENCES OF PREGNANCY AND TO MAKE IT CLEAR FOR MANY PEOPLE FROM THE SUDDEN INFANT DEATH ADVOCACY COMMUNITY, WE ARE CLEARLY ARTICULATING OUR CONTINUED EMPHASIS ON RESEARCH TO ADDRESS SUID AND SIDS AND INFANT MORTALITY. WITH REGARD TO CHILD DEVELOPMENT WE ALSO ARE ARTICULATING CONTINUED SUPPORT FOR STUDYING TYPICAL AND ATYPICAL CHILD DEVELOPMENT AND INCLUDED LANGUAGE THAT ADDRESSES SOCIAL AND ENVIRONMENTAL FACTORS IN DEVELOPMENT OF CHILD AND ADOLESCENT AND WE TALK ABOUT LIFE STAGE TRANSITIONS FOR INDIVIDUALS WITH INTELLECTUAL AND DEVELOPMENT AND PHYSICAL DISABLES AND WE PROVIDE A STRONGER EMPHASIS ON IMPACT OF AND TREATMENTS FOR EXPOSURE TO VIOLENCE STRESS AND TRAUMA. IN ADOLESCENCE WE CLARIFIED AREAS OF EMPHASIS I KNOW CATHERINE WAS CONCERNED ABOUT WHAT WE WERE GOING TO DO WITH ADOLESCENCE SPECIFIC CONCENTRATION AND BETTER UNDERSTANDING OF PUBERTY AND INCORPORATED ADOLESCENCE TO ADULT HEALTH CARE SYSTEMS DISABILITIES AND THOSE WITH CHRONIC HEALTH CONDITIONS AND WHAT YOU SHOULD NOT DO IN LOWER RIGHT PICTURE IS TEXT WHILE YOU ARE DRIVING. IN THE LAST AREA SAFE AND EFFECTIVE THERAPEUTICS AND DEVICES WE WILL CONTINUE TO FOCUS ON DEVELOPMENT AND VALIDATION AND DEVICES IT THAT EFFECT OUR CORE POPULATIONS. THE CONCLUSIONS FROM THE FEDERAL TASK FORCE ON MEDICATIONS TAKEN ABOUT I PREGNANT WOMEN AND LACTATING WOMEN HAS ALREADY INFLUENCED US. WE ALREADY SAW THERE IS A TREMENDOUS GAP IN KNOWLEDGE IN THAT AREA. WE WILL INCORPORATE WHAT WE ALREADY KNOW AND THIS WILL BE A LIVING DOCUMENT WHERE WE ARE ABLE TO AT LEAST INTERNALLY IF ADDITIONAL IMPLEMENTATION RECOMMENDATIONS WE WILL BE THEM INTO OUR INTERNAL WORKING PLANS AND WE ALSO WILL INTEGRATE THE USE OF CLINICAL TRIAL AND REAL-WORLD DATA SUCH AS ELECTRONIC HEALTH RECORDS AND RESEARCH REGISTRIES TO MEASURE EXPOSURES AND RESPONSES TO THERAPEUTICS AND DEVICES. RECENTLY NATURE MEDICINE, REALLY INTERESTING ARTICLE FROM CHINA IN WHICH THEY USED ELECTRONIC HEALTH RECORD LANGUAGE INFORMATION TO DICING DIAGNOSE 55 PEDIATRIC CONDITIONS. IMAGING IS A LOT EASIER TO ANALYZE WITH MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE. NATURAL LANGUAGE PROCESSING IS MUCH HARDER. AFTER READING THAT PAPER, I FEEL LIKE THIS -- THIS CAN BE DONE. IT IS REALLY A TREMENDOUS OPPORTUNITY FOR RESEARCH BOTH FOR US AND FOR MEDICATIONS AS WELL AS CHILD HEALTH AND OTHER AREAS OF RESEARCH FOR THE INSTITUTE. I WILL PAUSE HERE AND SEE IF THERE ARE QUESTIONS BEFORE WE MOVE ON. QUESTIONS IN TERMS OF THE TIMELINE? DO YOU FEEL WE ADDRESSED SOME OF THE COUNCIL'S CONCERNS? IT IS VERY QUIET. YES, TONY? >> LOOKS GREAT, DIANA. ONE THING I WONDERED ABOUT AS YOU TALKED ABOUT DIFFERENT MODEL SYSTEMS, IT WAS MOSTLY ANIMAL. ONE THING THAT WASN'T EXPLICITLY SAID WAS ABOUT USING HUMAN MODEL SYSTEMS CERTAINLY WITH DEVELOPMENT IT MAY BECOME LIMITED WITH VARIETY OF REASONS PARTICULARLY USING ES AND HUMAN ES AND IPS MODELS. IS THAT GOING TO BE PART OF THE PLAN AND EXPLICITLY STATED? >> DIANA BIANCHI: YEAH. I CAN'T REMEMBER OFFHAND IF IT IS EXPLICITLY STATED. IT SHOULD BE. AGAIN, HAVING COME FROM DOWNSYNDROME MEETING, THERE WERE MANY SESSIONS THAT ACTUALLY COMPARED NUMEROUS MOUSE MODELS FOR DOWN SYNDROME. BENEFITS AND LIMITATIONS OF USING THOSE MODELS VERSUS USING HUMAN IPSE. THAT IS CERTAINLY PART OF BASIC SCIENCE THAT I'M SURE WE ALREADY SUPPORT A NUMBER OF PROJECTS TAT I CAN'T RECALL OFF THE TOP OF MY HEAD. THAT IS -- THAT IS A TECHNOLOGY THAT IS ABSOLUTELY REVELLENT TO MANY OF THE THINGS THAT WE DO. YES, CLIFF? >> YEAH. I WOULD JUST SECOND THAT, THAT NOT JUST HAVING IPS DERIVED CELLS BUT BASED ON THAT ORGANIZE ONNOID SYSTEM OF DEVELOPING IS BECOMING INCREASINGLY POSSIBLE TO STUDY FORMATION OF REAL HUMAN ORGANS OR ORGANOIDS AND APPROXIMATELY HUMAN ORGANS IN CULTURE SYSTEM IT IS IMPORTANT COMPLEMENT BUT CAN'T BE EXCLUSION OF THE ANIMAL MODELS I THINK HAVING THEM TO BALANCE AND I APPRECIATE EFFORTS YOU WENT INTO IMPROVING THEM. I THINK IT WILL HAVE A STRONGER RESONANCE WITH THE RESEARCH COMMUNITY. >> DIANA BIANCHI: GREAT. YEAH. NO. I TOTALLY AGREE HAVING SEEN AMAZING IMAGES OF ORGANIZE ONNOID FORMATION IN BOTH HUMANS AND FERRETS. THEY SHOWED FERRET BRAIN DEVELOPMENT IF IN THIS MEETING. THIS IS STANDARD OF CARE OR STANDARD OF RESEARCH. REMEMBER, WE ARE TRYING TO LOOK FIVE YEARS INTO THE FUTURE. WE SHOULD AT LEAST BE CURRENT WITH WHAT PEOPLE ARE DOING NOW. WE KNOW IN FIVE YEARS IT WILL AT LEAST BE DIFFERENT. ANY OTHER QUESTIONS? OKAY. WE WILL HAVE A LITTLE FUN NOW. SO I WOULD LIKE TO THAFRJ CATHERINE GORDON WHO AGREED TO SERVE IN A LEADERSHIP ROLE ON THIS WORKING GROUP. WE WILL GET TO ALL OF THE PEOPLE THAT SPECIFICALLY WORKED ON IT. BUT, HOPEFULLY THIS WILL WORK. WAIT. BEFORE WE START, WE CURRENT WILL I HAVE A 62-WORD MISSION STATEMENT. AND AS PART OF THE STRATEGIC PLAN, WE WANTED TO MAKE SURE THAT OUR MISSION STATEMENT WOULD REFLECT OUR MISSION. IT REALLY HASN'T CHANGED, BUT WE WANTED TO MAKE SURE THAT THE STATEMENT REFLECTED OUR MISSION. OUR CURRENT MISSION STATEMENT IS 62 WORDS LONG. UNLIKE EVERY OTHER INSTITUTE AND CENTER WITH THE EXCEPTION OF THE NATIONAL LIBRARY OF MEDICINE, WE ARE THE ONLY INSTITUTE THAT DOESN'T HAVE THE WORDS RESEARCH OR TRAINING IN OUR MISSION STATEMENT. SO JUST TO SEE WHETHER PEOPLE UNDERSTAND OUR MISSION STATEMENT, WE ASKED AND WE REALLY APPRECIATE THE PEOPLE WHO VOLUNTEERED FOR THIS ACTIVITY. I WANT TO SPECIFICALLY THANK PAUL WILLIAMS, OUR DIRECTOR OF COMMUNICATIONS, WHO PUT TOGETHER THE VIDEO YOU WILL SEE. WE ASKED PEOPLE WHAT IS NICHD'S MISSION STATEMENT. >> AND ADVERSE CONSEQUENCES OF REPRODUCTIVE PROCESSES. >> NO NEGATIVE REPERCUSSIONS OF REPRODUCTION. >> THAT EVERYONE ACHIEVES THEIR FULL POTENTIAL. >> AND ALL CHILDREN HAVE AN EQUAL OPPORTUNITY. >> THAT ALL CHILDREN ARE GIVEN THE POTENTIAL TO LIVE HEALTHY, PRODUCTIVE, INDEPENDENT LIVES. >> FREE FROM -- >> FREE OF DISEASES AND DISABILITY. >> AND THERE WAS MORE. >> THE THIRD PART HAS SOMETHING TO DO WITH REHABILITATION. >> OPTIMAL REHABILITATION. >> REHABILITATION IS THE MOST IMPORTANT THING HERE. >> I CAN NEVER REMEMBER THAT PART. >> IN ADDITION, THE MISSION IS TO MAKE SURE THAT EVERY PERSON LIVES PRODUCTIVELY AND HEALTHY THROUGH OPTIMAL REHABILITATION. >> THROUGH OPTIMAL REHABILITATION. >> THROUGH OPTIMAL REHABILITATION. >> THAT'S IT. >> AUDIENCE: [APPLAUSE]. >> AGAIN, I WANT TO THANK PAUL WILLIAMS AND THE STAFF WHO WERE VERY SPONTANEOUS. AS YOU CAN TELL, THIS WAS NOT SCRIPTED. WE WANTED TO SEE DID PEOPLE INCLUDING MYSELF, COULD WE -- COULD WE STATE THE MISSION STATEMENT? CLEARLY, SOMETHING IS WRONG IF WE CAN'T STATE IT. HERE IS THE FULL MISSION STATEMENT. THIS IS THE CURRENT MISSION STATEMENT. MISSION OF NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED AND THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES FREE FROM DISEASE OR DISABILITY AND ENSURE THE HEALTH PRODUCTIVITY, INDEPENDENCE AND WELL-BEING FOR ALL PEOPLE THROUGH OPTIMAL REHABILITATION. IT IS LONG AND THAT IS WHY PEOPLE CAN'T REMEMBER IT. WE HAVE QUESTIONS AS TO WHETHER CAN WE REALLY ENSURE WHETHER EVERY PERSON IS BORN HEALTHY AND WANTED. WE WENT BACK TO CONGRESSIONAL LANGUAGE BACK TO 1962, THE FORMATION OF THE INSTITUTION. THE GENERAL PURPOSE OF THE KENNY ED SHRIVER -- IS THE CONDUCT AND SUPPORT OF RESEARCH, TRAIN SHGING HEALTH INFORMATION DISSEMINATION AND OTHER PROBLEMS WITH RESPECT TO GYNECOLOGICAL HEALTH -- HUMAN GROWTH AND DEVELOPMENT INCLUDING PRENATAL DEVELOPMENT AND POPULATION RESEARCH AND SPECIAL HEALTH PROBLEMS AND REQUIREMENTS OF MOTHERS AND CHILDREN. LATER ON, WHEN NCMRR JOINED US, JUST TO GIVE YOU THE LANGUAGE THERE, THE NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH WITHIN NICHD SUPPORTS RESEARCH AND TRAINING CONCERNING REHABILITATION OF INDIVIDUALS WITH PHYSICAL DISABILITIES. WE COORDINATE ACTIVITIES ACROSS NIH AND THE FEDERAL GOVERNMENT. OKAY? SO I WOULD LIKE TO EXPRESS MY GRATITUDE TO THE MISSION AND VISION STATEMENT WORKING GROUP AND VARIOUS MEMBERS ARE LISTED HERE INCLUDING RICHARD ELLISON WHO IS A MEMBER OF NATIONAL ADVISORY BOARD TO MEDICAL REHABILITATION RESEARCH AND CEO OF CEREBRAL PALSY FOUNDATION AND LONG CAREER IN ADVERTISING AND CATHERINE GORDON AS YOU KNOW IS A MEMBER OF OUR COUNCIL WHO WILL ACTUALLY BE PRESENTING THE NEW MISSION STATEMENT. I WON'T GET SHOT WHEN IT IS PRESENTED. NO, IF NO. JUST KIDDING. LESLIE ROT ENBERG WHO IS ON THE PHONE AND A MEMBER OF OUR ADVISORY COUNCIL AND WHO IS THE GENERAL MANAGER OF CHILDREN'S PROGRAMMING, MARKETING, AND COMMUNICATIONS AT PBS. SHE ALSO HAVE A LIFELONG CAREER IN MARKETING AND COMMUNICATIONS AND ALISON CERNICH IS DIRECTOR OF NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH AND STEPHANE PHILOGENE DIRECTOR OF OFFICE OF SCIENCE POLICY REPORTING AND PROGRAM ANALYSIS. PAUL WILLIAMS DIRECTOR OF OFFICE OF COMMUNICATIONS AND ELIZABETH BAYEDEN WHO IS CHIEF OF STAFF TO THE WORKING GROUP FOR NICHD OF OUR ADVISORY COUNCIL. WE CREATED A PROCESS AND FISH ESTABLISHED PARAMETERS AND NEED TODAY HAVE NEW MISSION STATEMENT COMPLY WITH CONGRESSIONAL LANGUAGE AND NEEDED TO HAVE WORDS RESEARCH AND TRAINING IF IN THE STATEMENT AND WE WANTED IT TO BE UNIQUE TO NICHD AND TO BE MORE CONCISE THAN THE CURRENT STATEMENT. IN A PREVIOUS ATTEMPT TO REFINE THE MISSION STATEMENT WHEN I SERVED ON COUNCIL INTERESTING I HAVE NO MEMORY OF THIS, BUT THIS ARCHIVE IS THE PERMANENT RECORD. MY COMMENTS AT THAT TIME WERE REVISED PROPOSED STATEMENT WAS NOT UNIQUE TO NICHD. I HOPE WHEN YOU SEE IT, YOU WILL SEE IT IS UNIQUE. THE PROCESS WAS AS FOLLOWS. WE REVIEWED MISSION STATEMENTS FROM OTHER ORGANIZATIONS. WE LOOKED AT ALL NIH INSTITUTES AND CENTERS AND LOOKED AT TOP NON-PROFIT ORGANIZATIONS. EACH MEMBER OF THE WORKING GROUP WAS GIVEN HOMEWORK. WE EACH DRAFTED UP TO FIVE POTENTIAL MISSION STATEMENTS. WE RECEIVED 27 POSSIBLE STATEMENTS AND WE HAD A CONFERENCE CALL IN WHICH WE DISCUSSED THEM. IT WAS LESS CONTENTIOUS THAN YOU WOULD THINK. WE ALL KIND OF LANDED ON THE TOP TWO CANDIDATES. WE CONSIDERED SEVERAL VARIATIONS ON THE TWO TOP CHOICE MISSION STATEMENTS BEFORE ARRIVING AT THE PROPOSED LANGUAGE. SO, AGAIN, THIS IS WHERE OUR MARKETING REPRESENTATIVES HELPED US. THEY WANTED US TO HAVE CERTAIN PARAMETERS, THAT THE STATEMENT BE CLEAR, CONCISE, INSPIRATIONAL, MEMORABLE, FORWARD-LOOKING, WHAT DO WE WANT TO ACHIEVE? AND AGAIN, IT IS UNIQUE TO NICHD. AFTER SELECTING TOP TWO CHOICES FOR MISSION STATEMENT, WE BRAIN STORMED IDEAS FOR A VISION STATEMENT AND WE DISCUSSED DRAFT STATEMENTS AGAIN AND SELECTED WORDS AND PHRASES THAT RESONATED AND CONSTRUCTED A NEW OPTION WITH GROUP CONSENSUS. IT IS CONCISE ENOUGH TO BE A TAG LINE AS WELL. LET ME SEE THE NEXT SLIDE. YEAH. THEN WE GO TO KATHY. SO IMPORTANT CONSIDERATIONS THAT EMERGED WERE THAT THE STATEMENT SHOULD BE BROAD AND NOT CALL OUT INDIVIDUAL DISEASES OR TOPICS. IT NEEDS TO BE INCLUSIVE OF ALL TO INCLUDE FULL SPECTRUM OF EEDS NICHD RESEARCH WITHOUT LISTING EVERYTHING EXPLICITLY. SOME WORDS AND PHRASES THAT CAME IMPORTANT INCLUDED RESEARCH AND TRAIN R TRAINING AND UNDERSTANDING HUMAN DEVELOPMENT, ADOLESCENCE, AND OPTIMIZING ABILITIES. NOW, THIS IS THE NEXT SLIDE. DRUM ROLL. I WILL HAND IT OVER TO CATHERINE. I THINK WE ARE AT THE RIGHT SLIDE. >> I WANT TO EMPHASIZE, DO NOT SHOOT THE MESSENGER. DIANA WILL HEAD FOR THE HILLS WHILE I STAND I WANT TO SHANK DELL LA AND ELIZABETH. I ENJOYED THIS OPPORTUNITY AND WE TRIED OUR VERY BEST AND WE REALIZED HOW MANY DIFFERENT POPULATIONS AND MISSIONS THAT WE SERVE AND WE TRY TO REPRESENT. I JUST WANT TO SECOND WHAT DIANA SAID. IT WAS VERY INTERESTING, THIS PROCESS, HOW THERE WERE MANY, MANY DIFFERENT POSSIBILITIES. WE LANDED IN THE SAME PLACE. WE TRIED TO PAY ATTENTION TO THAT. HERE IS OUR REVISED MISSION STATEMENT. THE UNIS KENNEDY SHRIVER INSTITUTE OF CHILD'S HEALTH AND DEVELOPMENT LEADS RESEARCH AND TRAINING TO UNDERSTAND HUMAN DEVELOPMENT AND IMPROVE REPRODUCTIVE HEALTH AND ENHANCE THE LIVES OF CHILDREN AND ADOLESCENCE AND OPTIMIZE ABILITIES FOR ALL. >> DIANA BIANCHI: REACTIONS? DEAD [SILENCE]. >> WELL, GOOD. THANK YOU. >> DIANA BIANCHI: I THINK IT IS 20 WORDS NOW. >> SHOULD I GO ON? >> YES. >> OKAY. EUNICE. >> I'M SURE YOU PROBABLY TALKED ABOUT THIS BUT IT SEEMS RATHER THAT TITLE OF THE INSTITUTE HAS WORDS HUMAN DEVELOPMENT AND MISSION HAS WORDS HUMAN DEVELOPMENT. OF COURSE WE WILL RESEARCH AND TRAIN TO UNDERSTAND WOULD IT BE NECESSARY IF IT SAID CHILD HEALTH AND HUMAN DEVELOPMENT. YOU KNOW WHAT I MEAN? JUST REPEAT. YOU PROBABLY THOUGHT ABOUT IT. >>WE KNEW SOMETIMES IT WOULD BE ACRONYM NICHD WE WANTED TO CALL IT THIS ONE MORE TIME. SPELLING IT OUT, YOU ARE RIGHT. IT IS REPETITIVE. THANKS TO YOU AND THE COMMITTEE FOR EFFORT TO DO THIS GOING FROM 62 WORDS TO THIS MIGHT HAVE BEEN QUITE AN EFFORT. I DO RECALL, HOWEVER, SOME DISCUSSION NOT JUST DURING COUNCIL BUT ON TWITTER ABOUT NOT INCLUDING THE WORD PREGNANCY IN THE STATEMENT AND WHETHER IT HAD COME UP BEFORE. OR PREGNANT WOMEN. OVER HERE WE FELT REPRODUCTIVE HEALTH ENCOMPASSED THAT. I DON'T REMEMBER. >> IT IS LIKE A ZEN EXERCISE. WE FUND RESEARCH THAT ENCOMPASSES A SPECTRUM OF REPRODUCTIVE HEALTH. AGAIN, REMEMBER THAT WITH THE STRATEGIC PLAN WE ARE SPECIFICALLY CALLING OUT MALE REPRODUCTIVE HEALTH AS WELL IN WHICH WE HAVE $30 MILLION INVESTMENT ALREADY. WE WANT -- YOU WILL BE HEARING ABOUT SUBSEQUENTLY IN THE NEXT PRESENTATION ABOUT SOME OF THE RESEARCH THAT WE FUND IN WOMEN'S GYNECOLOGIC DISORDERS. WE HAVE GYNECOLOGY AND MALE AND FEMALE REPRODUCTIVE HEALTH AND WE HAVE PREGNANCY. WE THOUGHT IMPROVE REPRODUCTIVE HEALTH WOULD BE A WAY OF IN A CONCISE WAY INCLUDING EVERYTHING WITHOUT BEGINNING TO SEPARATE IT OUT. WE REALLY DO SEE IT AS A LIFESPAN SPECTRUM THAT ACTUALLY MAY ALSO HAVE TRANCE GENERATIONAL IMPLICATIONS. SO, YOU KNOW, IT IS REALLY HARD WHEN YOU THINK ABOUT ALL OF THE THINGS WE HAVE TO INCLUDE IN A STATEMENT. I THINK THE COMMITTEE DID A FANTASTIC JOB IN CONSIDERING ALL OF THESE ELEMENTS. THANKS FOR THE QUESTION. >> ONE THING IS THE MORE SPECIFIC WE GOT, THE MORE WE WENT DOWN RABBIT HOLES IS WHAT WE FOUND. THE BROADER WE KEPT IT, THE BETTER. YEAH. >> I'M TRYING TO THINK THROUGH THE ZEN THING, BUT IT -- IT -- BETTER? >> YEAH. >> AGAIN, ON THE REPRODUCTIVE HEALTH, I'M JUST WONDERING ABOUT SOME OF THE ADULT GYNECOLOGIC CONDITIONS THAT ARE NOT NECESSARILY RELATED TO THE REPRODUCTIVE LIFE COURSE. AGAIN, IT MIGHT BE IMPLICIT OR MY READING OF IT, BUT I'M THINKING ABOUT SOME OF THE UROGYN TRIALS AND ADVANCED CONDITIONS IN OLDER WOMEN THAT WOULD BE LOOKED AT MORE GYNECOLOGIC HEALTH THAN REPRODUCTIVE HEALTH. AGAIN, MIGHT ME MEANING REPRODUCTIVE ORGANS NOT REPRODUCTIVE HEALTH. >> YEAH. REPRODUCTIVE ORGANS BUT IT IS A VERY GOOD POINT. ELIZA. >> ONE THING THAT CAME OUT OF DISCUSSION AND STRATEGIC PLANNING ARE REPRODUCTIVE ORGANS THEY REALLY DON'T BELONG TO ANY OTHER INSTITUTE. IN ADDITION TO THE PLACENTA, REPRODUCTIVE ORGANS FROM TIME OF EMBRYONIC DEVELOPMENT REALLY DO FALL IN OUR PORTFOLIO. SO IT IS IMPLIED IN THE LANGUAGE, BUT P NOT SPECIFICALLY CALLED OUT. I HOPE THAT THE STATE, YOU KNOW, THE WHOLE STATEMENTS AND STRATEGIC PLAN WILL CLARIFY THAT. >> SO JUST TO GET ONE PURELY POSITIVE CONCEPT. I MEAN, COMMENT. I'M ASSUMING THAT LOTS OF PEOPLE ARE SILENT. I GET THE ZEN OF IT. IT FEELS WELL-CRAFTED AND SHORT. I THINK IT CHECKS A TON OF BOXES RELATED TO WHAT YOU ARE TRYING TO ACHIEVE. I VERY MUCH LIKE THE WAY THAT THIS IS PUT TOGETHER. >> THANK YOU. >> ALL RIGHT. NEXT SLIDE. OKAY. THIS IS OUR REVISED VISION STATEMENT WHICH WE THINK WILL ALSO SERVE AS A TAG LINE. HEALTHY PREGNANCIES, HEALTHY CHILDREN, HEALTHY AND OPTIMAL LIVES. AND THE OPTIMAL IS THINKING ABOUT THE DEVELOPMENTAL DISABILITIES AND INTELLECTUAL. RIGHT. THE REHAB SIDE. YEAH. TH COMMENTS? >> I THINK IF YOU LOOK AT YOUR [INDISCERNIBLE]. I THINK THE TAG LINE. SORRY. THE TAG LINE, IF YOU LOOK AT YOUR BOOK, IT SAYS THAT IS OUR CURRENT TAG LINE. HEALTH RESEARCH THROUGHOUT THE LIFESPAN. WE WANTED TO MAKE IT A LITTLE BIT MORE SPECIFIC TO WHO WE ARE. AGAIN, BE INCLUSIVE OF THESE MAJOR POPULATIONS. SO I DON'T KNOW IF THERE ARE ANY COMMENTS ON THE VISION STATEMENT, BUT THAT IS WHAT WE HOPE TO ACHIEVE BY VIRTUE OF THE RESEARCH THAT WE FUND. >> I LIKE THE TAG LINE A LOT. THE PREVIOUS ONE WORKS. IT COVERED ALL OF THE BASIS BUT SOMETHING THAT YOU HAD TO CRAFT. THIS JUST FEELS GREAT. IT REALLY HITS IT. >> THANK YOU. >> ANY OTHER COMMENTS? YES, ALLEN? >> I LIKE IT. YEAH. >> GOOD. >> I THINK EVERYBODY CAN REMEMBER THESE. >> I KNOW. THEIR MISSION OF THE EMPLOYEES THERE CAN REALLY CITE THEIR MISSION STATEMENT AND THEY IMBED THAT INTO EVERYTHING THAT THEY DO. I WANT TO SAY THAT PERSONALLY, I FELT THE OLD OR THE CURRENT MISSION STATEMENT IS VERY DARK. YOU KNOW, WITH THE FOCUS ON PREVENTING WOMEN FROM HAVING HARM DURING REPRODUCTION WHICH IS A MUCH MORE POSITIVE VISION FOR THE FUTURE. SO YES? BARBARA? >> IT IS ME. I'M TAKING A LITTLE LONGER TO THINK ABOUT IT. GOING BACK TO MISSION STATEMENT ABOUT REPRODUCTIVE HEALTH, I REALLY APPRECIATE HOW YOU LOOKED AT THIS AS THE REPRODUCTIVE ORGANS. THAT IS HOW I ALWAYS FELT THAT NICHD WAS THE ONLY INSTITUTE THINKING OF REPRODUCTIVE ORGANS. AS SOMEONE THAT WORKS IN FERTILITY SPACE I FEEL WE ARE ALWAYS PART OF REPRODUCTIVE HEALTH BUT WAY IT IS VIEWED IS IN CONTRACEPTION AND PREGNANCY PREVENTION IN THE POLITICAL SPHERE. FOR ME, I LIKE THAT NICHD IS SAYING REPRODUCTIVE HEALTH IS ABOUT THE REPRODUCTIVE ORGANS AND ABOUT THAT LIFESPAN AND NOT JUST THIS ONE SOUND BITE PIECE THAT PEOPLE THINK OF. FROM MY PERSPECTIVE, I REALLY -- I IMMEDIATELY THOUGHT OF, WOW. I'M BEING INCLUDED. SO VERSUS BEING EXCLUDED. THAT IS AT LEAST HOW I READ IT. >> THANK YOU. I THINK THAT IS CERTAINLY THE WAY THAT WE WANTED IT TO BE RECEIVED, BUT IN THE VISION STATEMENT, WE WERE AIMING FOR SOMETHING ELSE BECAUSE AS I HAVE SAID BEFORE, I THINK THAT ONE OF THE REASONS WHY HISTORICALLY NICHD HAS BEEN LESS FUNDED COMPARED TO SOME OF THE OTHER INSTITUTES IS THERE IS A PERCEPTION THAT BOTH PREGNANCY AND CHILDHOOD ARE TIME-LIMITED. THERE IS A FAILURE TO APPRECIATE THE CONNECTION. YOU KNOW, WHAT IS HAPPENING TO YOU DURING YOUR FETAL LIFE INFLUENCES YOUR LIFE-LONG HEALTH. THAT IS REALLY MORE OF THE GOAL IF IN THE VISION STATEMENT TO MAKE THAT CONNECTION. THAT ENABLES US TO MAKE CLEAR PARTNERSHIPS WITH THE OTHER INSTITUTES TO SAY, YOU KNOW, WE ARE DOING THINGS IT THAT YOU MAY WANT TO STUDY, YOU KNOW, THESE COHORTS LATER ON. THAT HAS ALREADY HAPPENED WITH SOME OF OUR YOUNG FUNDED STUDIED MANY PEOPLE IN EARLY CHILDHOOD ARE NOW YOUNG ADULTS AND THEY ARE BEING STUDIED BY OTHER INSTITUTES. >> ALICE? >> GOING BACK TO YOUR TAG LINE, I LIKE IT. YOU DON'T LOSE THE WORD RESEARCH BECAUSE NOW IT IS BACK IN YOUR MISSION STATEMENT. SO YOU DON'T LOSE THAT RESEARCH. WHEREAS, BEFORE YOU DID NOT HAVE. YOU WERE SAYING THERE WAS NO RESEARCH MENTIONED IN YOUR OLD MISSION STATEMENT. NOW IT IS THERE SO YOU DON'T LOSE THAT RESEARCH PART OF IT. >> SO MY UNDERSTANDING WHAT A VISION STATEMENT IS SUPPOSED TO ENCOMPASS IS, YOU KNOW, AT THE END OF THE DAY IF YOU ACCOMPLISH YOUR MISSION, WHAT IS THE END PRODUCT? OUR END PRODUCT IS NOT RESEARCH FOR THE SAKE OF DOING RESEARCH. OUR END PRODUCT IS TO HELP PEOPLE BE HEALTHIER AS NIH TAG LINE OF ADVANCING THROUGH RESEARCH. THAT IS WHY IT IS THERE. IN OUR MISSION WE HAVE A CORE RESEARCH AND TRAINING MISSION. >> IT WAS BACKWARDS BEFORE. YOU HAD RESEARCH IF IN THE WRONG PIECE BUT NOW YOU GOT IT RIGHT. ALYCE. >> DOES ANYBODY ELSE HAVE ANY COMMENTS? I WANT TO THANK -- STEVE, YOU WERE LOOKING LIKE YOU MIGHT WANT TO SAY SOMETHING. IF NO? DWAYNE, YOU HAVE BEEN UNCHARACTERISTICALLY QUIET. >> I REALLY MARVEL AT HOW YOU THREADED THE NEEDLE ON BOTH OF THESE OBJECTIVES, SO CONGRATULATIONS. >> WELL, AGAIN, I WANT TO THANK THE WHOLE WORKING GROUP. IT WAS A LOT OF FUN. WE HAD OUR HOMEWORK AND WE ALL WORKED VERY HARD ON IT. THAT ENABLED US TO CONSIDER MANY DIFFERENT POSSIBILITIES. IT WAS A VERY RICH DISCUSSION. WE KEPT CIRCLING BACK TO THE SAME WORDS. THEY WERE THE ONES THAT WHETHER YOU WERE A SCIENTIST OR YOU WERE IN MARKETING, IT HAD THE SAME EMOTIONAL COMPONENT FOR ALL OF US. AND SO THAT IS HOW WE ENDED U WHERE WE WERE. BUT -- >> ONE MORE THING. I WANT TO AGAIN THANK ELIZABETH BAYEDEN WHO WAS THE T- PERSON BEHIND THIS. THERE WERE MANY DRAFTS 1 WORD VERSUS 2 AND YOU CAPTURED IT ALL THANK YOU SO MUCH. IT WAS A PLEASURE TO WORK WITH YOU. >> FOCUSED. THIS IS SOMETHING THAT COULD GO OFF THE RAILS BY NOTES AND HIGHLIGHTING MINOR TWEAKS HERE AND THERE, YOU KIND OF GOT US DOWN TO WHERE WE NEEDED TO BE. THANK YOU. >> OKAY. SO IF I COULD JUST HAVE THE -- WANT TO GO OVER THAT? >> SO WHILE DIANA GETS BACK TOT TABLE, I HAD A COUPLE HOUSEKEEPING THINGS TO MENTION TO FOLKS. YOU MAY HAVE NOTICED THAT THESE MICS ARE RATHER INSENSITIVE, I GUESS IS THE BETTER WAY TO SAY, YOU REALLY HAVE TO BECOME A ROCKSTAR WHEN YOU TALK ON THESE THINGS HAVE IT CLOSE TO YOUR MOUTH SO PEOPLE IN THE ROOM AND ALSO FOR THE VIDEO CAST TO ENSURE IT IS BEING PICKED UP FOR ALL OF THE FOLKS THAT ARE LISTENING IN ON. SECOND POINT, I WANT TO CIRCLE BACK REALLY QUICKLY TOO SINCE WE DO HAVE AN IF FEW MINUTES, CLIFF IN TERMS OF THE GROUP LOOKING AT R35, MY ASSUMPTION IS YOU WILL NEED SOME STAFF HELP WITH REGARD TO THAT AND THE MODELING AND PULLING THINGS TOGETHER AND SO FORTH. I WOULD LIKE TO PROPOSE ESSENTIALLY A CO-CHAIR TO WORK WITH YOU THAT IS A MEMBER OF THE STAFF. IT WILL PROBABLY BE DR. DENNIS TWAMBLY TO WORK WITH YOU AND THE COMMITTEE IN TERMS OF FORMULATING YOUR IDEAS TO BRING BACK TO COUNCIL. >> DIANA BIANCHI: SO DESPITE EVERYTHING THAT HAPPENED WITH THE AUDIO VISUAL DIFFICULTIES WE ARE AHEAD OF SCHEDULE, WHICH IS FABULOUS. AT THIS POINT I WOULD LIKE TO INTRODUCE DR. STACEY MISSMER WHO IS IN THE DEPARTMENT OF OBSTETRICS -- HUMAN MEDICINE AT MICHIGAN STATE UNIVERSITY IN EAST LANCING MICHIGAN MOST OF HER RESEARCH IS IDENTIFYING FACTORS THAT EFFECT RISK OF ENDOMETRIOSIS PARTICULARLY AMONGST YOUNG WOMEN AND GIRLS. HER RESEARCH TEAM CONFIRMED OR IDENTIFIED VARIATION IN POPULATION-BASED INCIDENCE OF ENDOMETRIOSIS ASSOCIATED WITH IN UTEROEXPOSURES BODY EXERCISE AND DIETARY INTAKE. SHE HAS BEEN CRITICAL IN STUDYING VALIDITY OF STUDY DESIGN AND ANALYTIC APPROACHES WE ARE HINDERED BY A LARGE POOL OF UNDERDIAGNOSED AND UNDERSERVED WOMEN AND GIRLS GIVEN THE DIAGNOSTIC DIFFICULTIES FOR ENDOMETRIOSIS. IN ADDITION, HER RESEARCH SUGGESTS GIRL AND WOMEN WITH ENDOMETRIOSIS MAY BE A HIGH RISK GROUP FOR AUTO IMMUNE DISEASE -- RE-ENFORCING IMPORTANCE OF LONGITUDINAL DISCOVERY. CRITICAL TO THE DISCOVERY IS DEFINING AND VALIDATING ENDOMETRIOSIS HETERO-JENAETY BY APPLYING PRECISION METHODS THAT REVOLUTIONIZED UNDERSTANDING OF RISK, TREATMENT, AND PROGNOSIS AMONGST CANCER SUBTYPES. WELCOME DR. MISSMER WHO WILL PRESENT ON ENDOMETRIOSIS TO GO TO THE NEXT PRESENTATION. ENDOMETRIOSIS A FUNDAMENTAL EXAMPLE FOR WOMEN'S HEALTH DISCOVERY. WELCOME, BEFORE MISSMER. >> AUDIENCE: [APPLAUSE]. >> STACEY MISSMER: THANK YOU SO MUCH. WHAT AN ONYR TO BE HERE WITH FRIENDS AND COLLEAGUES AND PEOPLE THAT I RESPECTED AND LEARNED FROM FOR SO VERY LONG. I'M HOPEFUL THAT PART OF THE DISCUSSION AND PART OF THE -- THE STATE OF OUR UNDERSTANDING OF ENDOMETRIOSIS AND IMPACT OF IT AS OF TODAY WILL HELP ALSO TO RE-ENFORCE THE THEMES YOU HAVE BEEN DISCUSSING OVER THE LAST COUPLE HOURS IN TERMS OF INTERRELATIONSHIP BETWEEN GYNECOLOGICAL HEALTH AND NICHD WHICH IS THE HOME FOF GYNECOLOGIC RESEARCH AND WHERE MINE AND MY COLLEAGUES FUNDING AND ALSO INTELLECTUAL DISCOURSE AND CONTRIBUTIONS TO VISION FOFR THE FUTURE HAVE ALWAYS COME FROM. SO WHAT IS ENDO MEETTRIOSIS? WHAT DO WE KNOW? WE KNOW THAT ENDOMEETTRIOSIS IS DEFINED BY GLANDS OR STROEMA REPRESENTING ENDOMETRIAL ISSUE THAT IS NOW GROWING AND THRIVING OUTSIDE OF THE UTERUS. [AUDIO CUT OUT]. BUT ALSO MAY BE INVOLVED IN WHY A DISREGULATION THAT MAY BE INVOLVED IN WHY PLAQUES MY GROW AND BE MAINTAINED OUTSIDE OF THE UTERUS. 1 IN 10 WOMEN ARE DIAGNOSED WITH ENDOMETRIOSIS VIA SIRJ CAL REPRESENTATION TO DATE AND SYMPTOMS WITH PELVIC PAIN AND INFERTILITY AND THOSE POPULATIONS WHEN THEY ARE EVALUATED WE GET UP TO 1/3 AND 50% AND SOME POPULATIONS ADOLESCENCE WITH CHRONIC PELVIC PAIN AND ESTIMATES ARE GREATER THAN 80% OF THOSE YOUNG WOMEN. THIS REPRESENTS EVEN AT THE 10% RANGE REPRESENTS 190 MILLION WOMEN WORLDWIDE. COSTS ARE HUGE AND ONLY ACCOUNT FOR DIAGNOSIS TREATMENT AND WORK PRODUCTIVITY AND QUALITY OF LIFE IMPACT AND ANNUAL US COSTS ARE 69 BILLION AND THIS IS EQUIVALENT TO CROHN'S AND RHEUMATOID ARTHRITIS. PEOPLE ARE SURPRISED TO HEAR THIS THIS FALLS IN REALM OF DIABETES IN COSTS OF THE US WE UNDERSTAND ENDOMETRIOSIS MAY REPRESENT A RISK OF GROUP OF SEVERAL OTHER LONG TERM AND CHRONIC HEALTH OUTCOMES WE KNOW WITH FAIRLY HIGH CERTAINTY CONSISTENT DATA WOMEN WITH ENDOMEETTRIOSIS DOUBLE IN OAFARIAN CANCER. THERE IS CONCENSUS IN SPARSE LITERATURE BUT APPEARS TO INCREASED RISK OF AUTO IMMUNE DISEASES AND STRONGEST EVIDENCE FOR RHEUMATOID ARTHRITIS AND LUPIS WHICH MAY BE RELATED TO SOME OVERLAPPING DISREGULATION OF IMMUNE SYSTEM. MOST RECENTLY THERE IS EMERGING DATA THAT WITH ENDOMETRIOSIS AND HIGHER RISK OF CARDIOVASCULAR DISEASE AND HYPERTENG AND MYOCARDIAL INFARCTION AND [INDISCERNIBLE] APPEARING BEFORE AGE OF 50. SYMPTOMS ARE THE PRIMARY AREA OF CLINICAL INTERACTION AND PRIMARY AREA OF IMPACT. 2/3 OF WOMEN WITH ENDOMETRIOSIS REPORT AND PRESENT WITH CHRONIC SEVERE PAIN SYMPTOMS SEVERE MENSTRUAL CRAMPING AT OTHER TIMES BESIDES MENSTRUATION BECOMES PART OF UNPREDICTABILITY THAT CAN HAVE LARGE LIFE IMPACTS PAINFUL INTERCOURSE URINATION AND THERE IS OVERLAP WITH [INDISCERNIBLE] AND OVERLAP WITH IRRITABLE BOWEL SYNDROME. SURVEY OF US WOMEN OVER 30,000 OF THEM THOSE REPORTED HAVING ENDO MEETTRIOSIS REPORTED EXPERIENCING ABOUT 18 BED DAYS PER YEAR A LITTLE OVER 1 TO 2 PER MONTH AND BED DAYS REPRESENTED DAYS DURING WHICH THEY WEREN'T CAPABLE OF CONDUCTING NORMAL ACTIVITIES OR RESPONSIBILITIES. MORE BROADLY, THERE HAVE BEEN LARGE INTERNATIONAL STUDIES 8 STUDIES LOOKING AT WOMEN WITH ENDOMETRIOSIS. CONSISTENTLY WE DIDN'T SEE MUCH HETERO-JENAETY ACROSS POPULATIONS OR DIFFERENT REGIONS AND HALF -- ABOUT 1/3 RANGE IN TERMS OF WHAT THEY REPORTED AS IMPACT. 1/3 REPORTED IMPACTFUL LIFECHANGING ASSOCIATIONS WITH WORK, SCHOOL, HOME ACTIVITIES, FAM ILLIAL RELATIONSHIPS AND SOCIAL RELATIONSHIPS. VERY IMPORTANT THING IN ENDOMETRIOSIS IS VARIATION AKROG CROSS LIFE FORCE IN WHAT THEY MEAN IN DISCOVERY AND WHAT WE CAN IMPACT ON BEHALF OF GIRLS AND WOMEN. PEAK INCIDENCE OF ENDO MEETRIOSIS DIAGNOSIS IS IN THE THIRTYIES SO THAT IS OVER 20 YEARS WHEN YOU QUERY AND COLLECT INFORMATION ON ONSET OF SYMPTOMS, 1/5 OF WOMEN HAD SYMPTOM ONSET BEFORE AGE OF 20 AND 2/3 HAD SYMPTOM ONSET BEFORE AGE OF 30. SO THE DISEASE PROCESS AND LIFE IMPACT IS FAR BEFORE THE ACTUAL FORMAL DIAGNOSIS. THIS IS PARTICULARLY IMPORTANT WHEN WE THINK ABOUT ADOLESCENCE. WE HAVE A COHORT OF ABOUT 1500 YOUNG WOMEN AND ADOLESCENCE IN BOSTON'S CHILDREN'S HOSPITAL. TO EBBINGUS THERE HAS BEEN ON COMPARING AND CONTRASTING ADOLESCENCE AND ADULTS. ACTUALLY, MUCH OF WHAT THEY REPORT IS QUITE SIMILAR. HERE IS ABOUT 60% OF THE ADULT WOMEN REPORT THAT PAIN FROM ASSOCIATE WITH ENDOMETRIOSIS IMPACTS THEIR WORK AND HOME LIFE AND ADOLESCENCE UP TO ABOUT 2/3 NOT DRAMATICALLY DIFFERENT WHERE WE START TO SEE VERY IMPORTANT LIFE WINDOW AND COURSE IMPACTS IS WHEN WE LOOK AT QUALITY OF LIFE AND HOW THIS IS ATORING WHO THEY ARE AND REALLY FOR ADOLESCENCE WHAT THEY BECOME. ADOLESCENCE IS SF36 DATA. BLACK LINE IS STANDARD US POPULATION SCORES. THE BLUE IS OUR PARTICIPANTS WITH ENDOMEETTRIOSIS. WHAT WE SEE ON PHYSICAL AND MENTAL FUNCTIONING SCORES IS THEY ARE NOT THAT DIFFERENT. WHERE WE SEE DRAMATIC DIFFERENCE IS IN SOCIAL FUNCTIONING AND WHAT IS SEEN MOSTLY AT THIS POINT ANECDOTE ALLEY WITH GROWING BODY OF LITERATURE IS HAVING TO DEAL WITH CHRONIC PAIN AND PAIN THAT IS STIGMATIZED AND THAT IS OFTEN DISMISSED THAT, AGAIN, CAN BE UNPREDICTABLE AND BE VERY ANXIETY PROVOKING AND VERY ISOLATING IS ATORING THEIR CURRENT SOCIAL RELATIONSHIPS BUT AT A CRITICAL DEVELOPMENTAL WINDOW IS ATORING WHAT THEY DREAM TO BECOME AND BELIEVE TO BECOME. THEIR SOCIAL NETWORK BUILDING AND ALL OF THE AFFECTS OF THEIR LIFE ARE TRULY ALTERED AT THIS POINT DUE TO THIS CHRONIC PAIN CONDITION. WE DON'T UNDERSTAND EDDIOLOGY OF ENDOMETRIOSISES. WE ARE AT 100 YEARS SINCE THE PUBLISHING OF [INDISCERNIBLE]. IT IS MENSTRUAL EF LIEU WENT THAT IS EXPELLED THROUGH THE CERVIX THAT FRAGMENTS MOVE UP THROUGH THE FALOPIAN TUBE AND UP INTO THE PERITONEAL CAVITY. STUDIES DEMONSTRATED TRYING TO VISUALIZE AND CAPTURE AN IMAGE OF RETRO GRADE DEMONSTRATION 96% OF WOMEN HAVE BEEN OBSERVED IN THE STUDIES AND THERE IS SOME EVIDENCE OF RETROGRADE MENSTRUATION. THIS IS PROBABLY ALL WOMEN HAVE SOME LEVEL OF RETROGRADE MENSTRUATION. HYPOTHESIS BECOMES WHAT IS DIFFERENT WITHIN ENDOMETRIOSIS? WE KNOW THOSE WITH MUNERRAL ANOMALIES OR OBSTRUCTION OR IMPEDED OUTFLOW ARE AT INCREASED RISK SPEAKING TO VOLUME OF ENDOMETRIAL EF LIEU ENTBUT MOST EXPERIENCE A TYPICAL AMOUNT AND WE LOOK AT PATHWAYS OF IMMUNE DISFUNCTION AND THERE IS STEM CELL EXPLORATION AND WE KNOW WE ARE NOW SEEING ACROSS GWA STUDIES SO FAR ONLY LOOKING AT WOMEN OF EUROPEAN ANCESTRY AND 14 LOCI THAT OVERLAP WITH STRONG HYPOTHESES AROUND 4 AND ESTROGENIC PATHWAYS AND ADHESION AND IMPLANTATION PATHWAYS. LOTS OF DISCOVERY TO BE DONE HERE BUT WE ARE AT VERY BASIC BUILDING BLOCKS OF THE FOUNDATION OF OUR UNDERSTANDING. WHEN WE THINK ACROSS THE LIFE COURSE, ONE THING THAT HAS BEEN IMPACTING OUR DISCOVERY IS THE REALET THAT MOST WOMEN ARE DIAGNOSED IN THEIR P MID THIRDIES AND DIAGNOSED WITH A PRESENTATION OF LONG-STANDING CHRONIC PAIN OR INFERTILITY. REALLY, WE NEED TO BE LOOKING AT THIS ADOLESCENT WINDOW FOR EMERGENCE OF SYMPTOMS. IF WE THINK ETIOLOGICALLY AND IF WE THINK ALONG LINES OF POTENTIAL PREVENTION AND MODIFIABLE RISK FACTORS WE NEED TO BE LOOKING IN THE VERY EARLY STAGE. INDEED AS DR. BIANCHI SAID BRIEFLY WE HAVE SEEN SIGNIFICANT SIGNIFICANCES IN SMALL STUDIES WE LOOKED IN LARGE POPULATIONS WE SEE FAIRLY ROBUST ASSOCIATIONS WITH BODY SIZE ACROSS LIFE COURSE. STARTING AT LOW BIRTH RATE IS ASSOCIATED WITH RISK OF ENDOMETRIOSIS DIAGNOSIS AS ADULT DD EXPOSURE IS FOUND TO DOUBLE THE RISK AND ASSOCIATION TO GESTATION LINK AND PREMATURITY. THAT IS A LITTLE ROBUST. WHEN WE LOOKED AT ADOLESCENCE, THESE DATA ARE AGAIN NOT AREA OF HIGH FOCUS BUT VERY CONSISTENTLY WE SEE EARLY [INDISCERNIBLE] AND LOW BMI AGAIN IN CHILDHOOD ERA IS ASSOCIATED WITH ENDOMETRIOSIS. INTERESTING AND PERPLEXING AND ROBUST AREA WE ARE UP TO A DOZEN STUDIES SEEN ASSOCIATION WOMEN AS CHILDREN IN ADOLESCENCE WERE LIKELY TO HAVE SUNBURNS AND HIGHER NUMBER OF MOLES AND DISPLASTIC NEVI THERE IS SUGGESTION OF ASSOCIATION WITH INCREASED MELANOMA WE DON'T COMPLETELY UNDERSTAND BUT WE ARE SEEING IT IN MULTIPLE DIFFERENT STUDIES. ADULTHOOD LOTS MORE DATA HERE SHORTER MENSTRUAL CYCLES LEADING TO HYPOTHESES TO MENSTRUAL EF LIEUENT EXPOSURE NULLIPARITIY AND AGAIN SKIN CANCER ASSOCIATIONS HERE IS WHERE ENVIRONMENTAL TOXIN RESEARCH HAS BEEN. ANIMAL DATA IS VERY STRONG FOR DIOXINS AND PERRIST ANO CHLORINES HUMAN DATA HAS BEEN DIFFICULT IN PART BECAUSE IDENTIFYING POPULATIONS WITH ALL DATA NECESSARY AND CRITICAL TEMPORAL WINDOW IF WE CAPTURE THIS INFORMATION DURING ADULTHOOD WE ARE ALMOST CERTAINLY MISSING ED LOGICAL AND POTENTIALLY CAUSAL WINDOW. DIET AREA OF EXPLORATION SHOWING INTERESTING ASSOCIATIONS STRONG ASSOCIATIONS WITH UNHEALTHY FATS AND WITH RED MEAT AND PROTECTIVE ASSOCIATIONS OMEGA 3 FATTY ACIDS. CRITICAL AREA HERE STALLING DISCOVERY IS VERY FEW STUDIES HAVE BOTH ENDO MEETTRIOSIS PELVIC PAIN AND DIETARY DATA. CRITICAL ISSUE FOR MOST WOMEN AND IN DISCOVERY IS CONSIDERABLE DELAYED DIAGNOSIS GOING TO THE GLOBAL STUDY OF WOMEN'S HEALTH ACROSS EIGHT COUNTRIES FAIRLY HOMOGENEOUS ACROSS COUNTRIES AVERAGE TIME TO DIAGNOSE IS 7 YEARS FROM ONSET. CRITICAL PUBLIC AND CLINICAL IMPACT IS THAT THIS DIAGNOSIS IS OCCURRING OVER TIME PERIOD DURING WHICH GIRLS AND WOMEN ARE SEEING MULTIPLE CLINICIANS OF MULTIPLE SPECIALTIES. TYPICAL COURSE WOULD BE TO PRESENT TO PRIMARY CARE PHYSICIAN AND A PROPORTION OF THOSE GIRLS AND YOUNG WOMEN ARE NOT REFERRED ON. THOSE THAT ARE WILL OFTEN BE REFERRED TO GASTROENTOLOGY AROUND THEIR SYMPTOMS AND HAVE FULL WORKUPS AND LENGTHY DIET CHANGES AND THOSE THINGS THEY ARE DIAGNOSED WITH IRRITABLE BOWEL SYNDROME. IT IS DURING MULTIPLE STEPS THAT THOSE WHO SUCCESSFULLY ACHIEVE DIAGNOSIS REFER TO GYNECOLOGIST AND ONE WITH EXPERTISE. OTHER CRITICAL THING TO CONSIDER HERE IS WITH STANDARD GYNECOLOGIC TEXTBOOKS INTO THE EARLY 80S OR MID 80S THERE IS A COMMENT IN PAPER AS RECENTLY AS 2003 THAT RE-ENFORCES AND REFERS TO HIGH-RISK POPULATION BEING MOSTLY AFFLUENT WHITE WOMEN AND COMMENTS ABOUT BEING CAREER DRIVEN WOMEN OR COMMENTS ABOUT BEING TYPE A PERSONALITIES. REALLY, THOSE CHARACTERISTICS THAT WOULD BE ASSOCIATED WITH PUSHING THROUGH A SYSTEM TO GET DIAGNOSIS THAT IS DIFFICULT TO ACHIEVE. WE REALLY DON'T KNOW WHAT UNDERLYING PREVALENCE OF THIS DISEASE IS OR KNOW IF THE CHARACTERISTICS OF THOSE THAT WERE CURRENTLY MISSING DIFFERED IN AN INFORMATIVE WAY FROM THOSE WE WERE CAPTURING. MAJOR OBSTACLES FIRST DRIVEN IS DEFINITIVE DIAGNOSTIC IS SURGICAL VISUAL VISUALIATION. THERE IS BARRIERS TO THAT, THAT INCLUDE HESITATION APPROPRIATE HESITATION TO REFER FOR SURGERY FOR EVALUATION. WE HAVE NO BLOOD OR URINE WORK AROUND ENDOMETRIAL BIOPSY MARKERS BUT BUT NONE ARE SPECIFIC ENOUGH AND THERE IS LACK OF UNDERSTANDING OF THE DISEASE IT IS VERY COMMON FOR ADOLESCENCE TO BE TOLD THAT ADOLESCENCE DON'T GET ENDOMEETTRIOSIS AND VERY COMMON FOR NOT JUST FAMILY MEMBERS AND INDIVIDUALS BUT ALSO MEDICAL PROFESSIONALS TO BELIEVE THAT PELVIC PAIN IS NORMAL MENSTRUAL PAIN IS THE ONLY PAIN EVER DEFINED AS NORMAL. WE ARE YET TO FIND ANOTHER EXAMPLE WHERE PAIN IS DEFINED AS NORMAL. GIVEN THAT NORMAL MENSTRUAL PAIN WHAT IS THE THRESHOLD NOW OF WHAT WE HAVE CROSSED THAT NOW THIS IS ACTUALLY A CLINICAL ISSUE THAT NEEDS TO MOVE FORWARD? WE ALSO HAVE A NORMALIZATION WHERE GIRLS AND WOMEN ARE IN FAM MLYS WHERE MANY PEOPLE HAVE EXPERIENCED MANY WOMENS IN THE FAMILIES EXPERIENCED THOSE SYMPTOMS. AGAIN, IF IT CAN BECOME NORMALIZED. WE KNOW 65% OF WOMEN WITH ENDOMETRIOSIS RECEIVE A FORMAL MISDIAGNOSIS ON THEIR PATH. US SURVEY 1,000 WOMEN. 46% SO ABOUT HALF OF THEM SAW MORE DOCTORS BEFORE THEIR DEFINITIVE DIAGNOSIS. THAT IS WHAT WE KNOW ABOUT ENDOMEETTRIOSIS. WHAT IS ENDOMETRIOSIS WITH QUESTION MARK IN BOLD. THERE IS HUGE HETERO-JENAETY IN MACROASPECTS AND IN MICROASPECTS. THERE IS GREAT [INDISCERNIBLE] IN SUPERPERICONTINUE EEL CALLED END INFILTRATING TO THE TISSUE LAYERS. THEY OVERLAP BUT DON'T COMPLETELY OVERLAP AND WE STILL DON'T QUITE UNDERSTAND WHAT THE PATTERNS ARE. SOME WOMEN EXPERIENCE LARGE AMOUNTS OF SCARRING AND ADHESION WITH ENDOMETRIOSIS AND SOME NOT AT ALL. 1/3 HAVE PRESENT WITH INFERTILITY. 2 TO 3 TIMES OF THE GENERAL RISK OF POPULATION. WE KNOW ABSOLUTELY NOTHIN AT THIS MOMENT ABOUT INFORMATIVE MOLECULAR OR SOMATIC PHENOTYPES OF THE TISSUES ITSELF. THESE ARE IMAGES OF ENDOMETRIOSIS. ON THE LEFT -- SORRY. YEAH. THE LEFT FOR YOU IS IMAGES OF ADHESIONS AS TISSUES BUILD OFF AND SLOV OFF WITH MENSTRUAL CYCLE YOU GET ORGANS OF PERICONTINUE EEL CAVITY AND CENTER AT TOP IS POWDER LESION THIS IS CLASSIC DEFINITION OF ENDOMEETTRIOSIS. FOR LONG TIME UNLESS THIS LESION WAS PRESENT THEY DIDN'T GET DEFINITIVE ENDOMEETTRIOSIS DIAGNOSIS. THERE ARE ALL DIFFERENT LESIONS ALL THIS IS ENDOMETRIOSIS WITH GLANDS AND STROMA AND CHOCOLATE CYST ON THE RIGHT. AGAIN, THIS IS ALL ENDOMETRIOSIS. THESE ARE TWO EXTREMES FROM THE CURRENT STAGE 1 TO STAGE 4. IT IS OBVIOUS TO SEE HOW STAGE 4 WOULD BE IMPACTING FERTILITY, FOR EXAMPLE. YET INFERTILITY SPECIALISTS SEE STAGE 1 AS OFTEN IF NOT MORE IN THEIR PRACTICE THAN STAGE 4. FASCINATINGLY, THIS -- THESE TWO IMAGES, NO CORRELATION WITH PAIN SYMPTOMS. NO CORRELATION WITH TREATMENT SELECTION. NO CORRELATION WITH TREATMENT RESPONSE. THERE IS A HUGE RESPONSIBILITY FOR DISCOVERY HERE THAT AGAIN GIVEN LEAPS AND BOUNDS OF TECHNOLOGY IS RIPE FOR EXPLORATION. AS YOU KNOW, CANCER HAS BEEN REVOLUTIONIZED IN THE LAST 15 OR SO YEARS IN TERMS OF SUBPHENOTYPING. BREAST CANCER FOR EXAMPLE WE KNOW THESE PHENOTYPES ARE ASSOCIATED WITH PROGNOSIS. UPPER BLOCK THIS IS SURVIVAL ACROSS FOUR PHENOTYPES AND WE KNOW PHENOTYPES ARE DIFFER ENNATETIVELY ASSOCIATED WITH RISK AND PREVENTIVE FACTORS AND DIFFERENTIALLY ASSOCIATED WITH TREATMENT SELECTION. THAT IS NEXT CRITICAL AREA FOR ENDOMETRIOSIS DISCOVERY. THERE IS NO ALGORITHM FOR DISCOVERING WHAT THE PROEMENT TREATMENT IS. IT IS -- WITH OVER-THE-COUNTER PAIN MEDICATIONS AND OPIOIDS CHRONIC PELVIC PAIN IS A PLAYER IN CURRENT OPIOID CRISIS AND IMPAIR -- WHICH DO WORK FOR SOME WOMEN AND MOST OF THEM CAN BE TAKEN FOR A SHORT AMOUNT OF TIME. MOST OF THEM COME WITH SIDE-EFFECTS INCLUDING IMPACT ON BONE DENSITY AND THINKING ABOUT EXPOSURES IN ADOLESCENCE IN PARTICULAR IS CRIT CALLING. SURGERY FOR EXCISION OR OBLATION OF LEGIONS SOME PATIENTS HAVE ONE SURGERY AND BECOME SYMPTOM FREE THAT IS NOT THE CASE FOR MANY. WHEN DO SURGY AND SOME HAVE HAYDNED PAIN SYMPTOMS THAT OCCURS FOR SUBPOPULATION. DEFINING THE GROUPS IS ABSOLUTELY CRITICAL AND ALSO EXPLORING PATHWAYS OUTSIDE OF THE HORMONAL PATHWAYS HAS BEEN PRIMARY AREA OF DISCOVERY. THIS PAST YEAR A NEW DRUG CAME TO MARKET THAT IS STILL IN HORMONAL PATHWAY AND FIRST NEW DRUG IN ALMOST 20 YEARS. IT CAN'T EMPHASIZE ENOUGH IMPORTANT NEXT LEAP HERE IS DEFINING HETERO-JENAETY AND CONSIDERING WHAT IT MEANS IN MATERIALS OF WHY PERHAPS WE HAVEN'T BEEN SUCCESSFUL AT FINDING DIAGNOSTIC ONE SIZE FITS ALL DOESN'T FIT FOR ENDOMETRIOSIS WHEN I TALK TO STUDENTS ABOUT THIS AND SHOW PICTURES I TRY TO USE EXAMPLE WE WOULDN'T BE ABLE TO LOOK AT A BREAST CANCER TUMOR AND DISCERN THERE ARE INFORMATIVE DIFFERENCES. WE KNOW THERE ARE EXCEPTION ALGLY IMPORTANT DIFFERENCES WE CAN TAKE PEOPLE WHO HAVEN'T SEEN ENDOMETRIOSIS BEFORE AND KNOW THERE ARE SUBTYPES HERE THERE MUST BE CRITICAL AND INFORMATIVE SUBTYPE DZ FOR WHO IS AT LONG-TERM RISK OF OVARIAN CANCER FOR EXAM. UNFORTUNATELY WE ARE SEEING AN INCREASE IN PROPHYLACTIC BILATERAL OOFER ECT IT MY WITH WOMEN WITH ENDOMEETTRIOSIS. FOR PUBLIC PRACTITIONERS THAT IS SOMETHING WE HAVE TO DEFINE MUCH MORE BETTER WHO IS AT RISK. TO DEFINE THE SUBTYPES WE DON'T KNOW WHAT PREVALENCES AND INTERACTIONS ARE. DR. BIANCHI MENTIONED EARLIER ELECTRONIC MEDICAL RECORDS AND DATA. IMAGING AND SOME OTHER FIELDS, THERE IS UPTICK IN DISCOVERY THAT WILL HAVE I HAVE SHORT IMPACTS. ONE DIFFICULTY OR KEY DIFFICULTY FOR NEXT ERA OF BIG DATA IS ENDOMETRIOSIS IS NOT ROUTINELY RECORDED AND V- PELVIC PAIN IS NOT ROUTINELY RECORDED CAPTURING THAT DATA IS DIFFICULT. WE HAD INITIATIVE WE HAD CONSENSUS ACROSS 35 STAKEHOLDERS IN 27 COUNTRIES AND VEMED TOGETHER SURGICAL VISUALIZATION RECORDING TOOL AND LOTS OF WHAT WAS DONE HERE WITH JERM AN BUCK LIEUIS AND DATA THEY WERE COLLECTING AND -- WE ARE REALLY THRILLED IN JUST FOUR YEARS TIME WE HAVE 25 CENTERS IN 17 COUNTRIES WHO PUT THEIR HANDS UP AND ARE LISTED ON OUR WEBSITE AS COLLECTING INFORMATION AND USING TOOLS AND INTERESTED COLLABORATION WE HOPE IT WILL LEAD THE FIELD IN LEAPS AND BOUNDS OVER 13,000 COMPLETED QUESTIONNAIRES AND OVER 6,000 BLOOD SAMPLES. THIS IS NOT OVERSTATING BUT OVERSIMPLIFYING DATA THAT WE KNOW TO BE IMPORTANT TO COME INTO PLAY. WE ARE STARTING WITH ENDOMEETTRIOSIS WE HAVE FUNDING IN NICHD AND LOOKING AT EPIGENETICS AND MET AB LOAMICS AND PROETEE OHMIC APPROACHES AND INTERACTION WITH BOTH OTHER FIELDS AND DISEASE STATES AND HEALTH CONDITIONS THAT COMES TO ANOTHER CRITICAL THING IS THAT ENDOMETRIOSIS IS -- AND GYNECOLOGIC DISORDERS ARE A PERFECT EXAMPLE OF BUT ALSO OPPORTUNITY FOR COLLABORATION ACROSS INSTITUTIONS THAT TACKLING THIS NEEDS EXPERTS IN PAIN AND PAIN MANAGEMENT AND PAIN SYSTEMS AND NEEDS EXPERTS IN IMMUNOLOGY AND INFLAMMATORY DISEASES AND EXPERTISE IN VARIOUS TECHNOLOGIES AND DYNAMIC EPIGENETIC AND GENETIC DISCOVERY. IT WON'T BE SOLVED LOOKING JUST WITHIN THE SINGLE ORGAN SYSTEM. FUTURE BASED ON WHAT WE ARE SEEING IN CANCER IS PHENOMENALLY EXCITING AND OPPORTUNITY TO CAPITALIZE ON TECHNOLOGIES THAT HAVE BEEN SUCCESSFUL IF IN THE KNOWLEDGE MEANS WE WILL LEAP FOWARD VERY, VERY QUICKLY IN THIS FIELD. CRITICAL THING FOR ENDOMETRIOSIS IS AGAIN A WONDERFUL EXAMPLE IF IN WHAT WE MEAN AND PUSHING FOR WHAT WE MEAN IN PRECISION MEDICINE. WHEN WE CAN STRATIFY PATIENTS APPROPRIATELY BY MOLECULAR MARKERS AND SYMPTOM OTOLOGY AND BY DEMOGRAPHICS WE ALMOST ALWAYS IN THE FOOTPRINT HAVE EXTRA LAYER OF PERSONALIZATION WHERE THE GIRL OR WOMAN IS IN HER LIFE COURSE AND WHAT REPRODUCTIVE GOALS AND PRIMARY SYMPTOMS ARE AND WHAT TREATMENT APPROACHES ARE ACCEPTABLE AND WHY OR WHY NOT? THIS DIALOGUE WITH THE PRACTITIONER AND DIALOGUE LENS IN POPULATION SCIENCE WILL BE ABSOLUTELY CRITICAL. AGAIN, I THINK IT IS A PERFECT EXAMPLE WHY STRATIFICATION ALONE WON'T GET US TO WHERE WE NEED TO BE FOR HEALTH AND WELLNESS AND GIRLS WITH ENDOMETRIOSIS. RAPID ACCURATE DIAGNOSTICS IS I WOULD ARGUE NEXT TO THE INFORMATIVE SUBTYPING WHICH FRANKLY MIGHT BE WHAT IS HOLDING UP DIAGNOSTICS DISCOVERY WILL ABSOLUTELY CHANGE THE WORLD NOT ONLY BECAUSE IT WILL PUT DIAGNOSIS HOPEFULLY IN THE HAND OF FIRST-LINE PRACTITIONERS PEDIATRICIANS AND FAMILY CARE AND GENERAL PRACTITIONERS AND HOPEFULLY RAPIDLY TELL US WHAT THE MAGNITUDE OF THIS DISEASE AND IMPACT OF IT IS THAT WE DON'T UNDERSTAND AND SHORT AND LAENG THINK DIAGNOSIS TO REDUCE COSTS AND LIFE IMPACT AND ALSO MAY ALLOW US TO REDUCE RISK OF INFERTILITY AND CHRONIC LONGER TERM COMPLICATIONS OF ENDOMETRIOSIS. THE OTHER POINT AT THE VERY BOTTOM IS WE HAVE HUGE BIOREPOSITORIES AND LARGE COHORTS CANCER COHORT CONSORTIUM AT NCI HAS COHORTS THAT HAVE FOLLOWED MILLIONS OF WOMEN FOR MORE THAN 30 YEARS. NOT ONE OF THE COHORTS HAS ENDOMETRIOSIS HAS THAT. IF WE HAD A BIOMARKER THAT COULD BE TESTED IN LARGER REPOSITORIES IT WOULD OPEN UP A WHOLE NEW AREA OF DISCOVERY AND OPPORTUNITY. IN SUMMARY, WE KNOW ENDOMETRIOSIS IS PREVALENT AND IMPACTFUL AND KEY DISCOVERY POINTS IS SUB TYPING AND DIAGNOSTICS AND THINKING OF CRITICAL WINDOWS OF DISCOVERY AND WILL DEMAND MULTIDISCIPLINARY TEAMS ACROSS MANY AREAS OF SCIENCE, BUT I -- YOU KNOW, I HAVE LOVED THIS FIELD FOR SO LONG BECAUSE THERE IS SO MANY QUESTIONS TO ANSWER DR. GORDON AND I A WONDERFUL MENTOR OF MINE SAY IT THAT WHEN WE SEE TRAINEES THE SPARK OF NEVER RUNNING OUT OF QUESTIONS IS CRITICAL LITMUS TEST. SO MANY WONDERFUL QUESTIONS THAT WE HAVE. I WILL CONCLUDE WITH THAT. THANK YOU. >> [INDISCERNIBLE] THAT WAS FANTASTIC. THANK YOU SO MUCH. I WAS ON THE EDGE OF MY SEAT. YOU COVERED SO MANY OF THE THINGS I HOPED YOU WOULD COVER. SO I'M WITH AN ORGANIZATION CALLED RESOLVE THE NATIONAL INFERTILITY ASSOCIATION. AS YOU HAVE POINTED OUT, MANY WOMEN FIRST FIND OUT THEY ARE -- THEY EVEN HAVE ENDOMETRIOSIS BECAUSE THEY ARE HAVING TROUBLE CONCEIVING AND SEEING A SPECIALIST AND FIRST TIME THEY EVEN LEARN ABOUT ENDOMETRIOSIS. PATIENT ADVOCATE WE DO LOTS IN THIS SPACE AND OTHER ENDOMETRIOSIS ORGANIZATIONS AS WELL. BUT THERE IS ALSO A PROBLEM WITH WHO THE CAREGIVER IS FOR THE WOMAN WITH ENDOMETRIOSIS. WE TALKED ABOUT DIAGNOSIS HAPPENING IN THEIR MID 30S AND SOME A LITTLE LATER. ONCE REPRODUCTIVE ENDOCRINOLOGIST HELPS THEM GET PREGNANT AND SENDS THEM ON THEIR WAY AFTER THAT DIAGNOSIS THERE IS A BIG GAP WHO DO THEY GO TO AND SEE THAT IS THE FIRST THING TO POINT OUT WHO IS THE CAREGIVER FOR THEM FOR THE REST OF THEIR LIFE AND TALK ABOUT HAVING OPTIMAL LIFE THINKING ABOUT NICHD'S MISSION, WHERE DO THEY GO? OF THE OTHER THING I WANT TO MENTION IS I WAS PART OF AN INTERNATIONAL GROUP WORKING ON CORE OUTCOMES FOR ENDOMETRIOSIS RESEARCH FOR CLINICAL RESEARCH. WE WILL BE ANNOUNCING WHAT THE CORE OUTCOMES ARE FOR ENDOMETRIOSIS VERY SOON. I'M READING THE ABSTRACTS THIS WEEK. THEY WILL BE IN ALL OF THE JOURNALS. IT WILL BE ANY RESEARCH -- CLINICAL RESEARCH ON ENDOMETRIOSIS WILL HAVE TO REPORT ON SPECIFIC CORE OUTCOMES FOR ENDOMETRIOSIS. I'M EXCITED ABOUT THAT AS WELL. IF YOU CAN TOUCH ON WHO THE CAREGIVER IS ONCE THE DIAGNOSIS IS MADE THAT WOULD BE GREAT. >> ABSOLUTELY. RAISES SEVERAL QUESTIONS. YOU ARE ABSOLUTELY CORRECT THAT A -- PROBABLY 1/5 TO 1/4 OF WOMEN WITH ENDOMETRIOSIS WE KNOW HAVE BEEN DEFINITIVELY DIAGNOSED WITH IT DISCOVERED ENDOMETRIOSIS WITH WORKUP OF ENDOMETRIOSIS TREATMENT. WE HAVE TO KEEP SHINING LIGHT ON REALITY THAT WE KNOW THROUGH US VERY ROBUST NATIONAL DATA ONLY 50% OF THE WOMEN THAT MEET DEFINITION OF INFERTILITY ENGAGE WITH A HEALTH CARE PRACTITIONER AT ALL. ONLY HALF OF THOSE GO ON TO HAVE ANY TREATMENT AND IT GETS SMALLER AND SMALLER DEPENDING ON TYPE OF TREATMENT AND WHEN YOU HAVE THOROUGH EVALUATION. THERE IS ACCESS TO CARE AND KNOWLEDGE ISSUE IN THIS FOOTPRINT THAT IS HUGE AND OVERLAPPING WITH ENDOMETRIOSIS. I THINK THE ISSUE ABOUT WHERE A WOMAN SHOULD GO NEXT IS IF SHE HAS BEEN EXPERIENCING PELVIC PAIN AND DIDN'T REALIZE IT WAS ENDOMETRIOSIS UNTIL INFERTILITY HAPPENED THAT PATHWAY HAS TO ENGAGE AROUND PAIN MANAGEMENT POST FERTILITY CARE AND HOW TO MANAGE PAIN EVEN THOSE DIAGNOSED BEFORE INFERTILITY EXPERIENCE HOW TO MANAGE PAIN WHILE CONCEIVING IS YOU'VE ISSUE AGAIN PRIMARY TREATMENT IS OVARIAN SUPPRESSION. THAT AREA BECOMES QUITE COMPLICATED. I THINK ONE OF THE THINGS AROUND THAT WE ARE GETTING BETTER AT BUT JUST STARTING TO IS THAT THROUGH SOCIETIES LIKE INTERNATIONAL PELVIC PAIN SOCIETY AND ASSOCIATION FOR THE STUDY OF PAIN, THAT REPRODUCTIVE ENDOCINOLOGY AND INFERTILITY SPECIALISTS DON'T TRAIN IN PAIN MANAGEMENT. THEY ARE THE PRIMARY CARE PHYSICIAN FOR ENDOMETRIOSIS WHICH IS PRIMARILY PRESENTING WITH PAIN. THAT DISCONNECT IS A HUGE THING THAT NEEDS TO BE ADDRESSED. >> I'M INTERESTED IN THE POSSIBLE DIET ASSOCIATION WITH ENDOMETRIOSIS YOU MENTIONED PROTECTIVE FATS OF [INDISCERNIBLE]. >> YES. THANK 4 CATCHING IT THAT. I DIDN'T SAY ANYTHING OUT LOUD ABOUT KERSIVEROUS VEGETABLES. LE INTERESTINGLY WE SEE A LOWER RISK WITH HIGHER FRUIT AND VEGETABLE INTAKE. THAT LOWER RISK IS EMERGING WITH A FAIRLY LOW DIFFERENCE IN INTAKE. WE ARE SEEING IT AT ABOUT THE INCREASE OF ONE ADDITIONAL FRUIT OR VEGETABLE PER DAY THAT SEEMS MORE A BIAS OF OVERALL HEALTHIER DIET OR LIFESTYLE. WE SEE INCREASED RISK WITH CISSIVEROUS VEGETABLE INTAKE. NOW, REMEMBER, EVERY TIME I SEE INCREASED RISK IT IS INCREASED RISK OF DIAGNOSIS. NO WAY RIGHT NOW OF DEFINING INCREASED RISK OF THE DISEASE ITSELF. OUR HYPOTHESIS IS CISSIVEROUS VEGETABLES WE KNOW CAN BE ASSOCIATED WITH INCREASED GI SYMPTOMS ABDOMINAL BLOATING AND PAIN AND MAY BE THAT GIRLS AND WOMEN WITH HIGHEST INTAKE OF THESE VEGETABLES EXPRESS SYMPTOMOLOGY THAT GETS THEM TO THE DIAGNOSIS. IT IS DIFFICULT I HATE TO DO CAUSAL CONCLUSIONS UNTIL WE CAN GET TO THE ISSUE OF WHAT DRIVES DIAGNOSIS AND WHAT IS UNDERLYING THE PHYSIOLOGY OF THE DISEASE. >> I WANT TO MAKE SURE I GET CLOSE ENOUGH HERE. YOU MENTIONED THE LINK POTENTIAL LINK TO OVARIAN CANCER. >> YEAH. >> HAS THERE BEEN ANY LINK DETERMINED RELATING TO PERITONEAL CANCER IS THAT SOMETHING YOU PRIMARY PERITONEAL CANCER. >> STACEY MISSMER: NO. THAT IS BECAUSE ONLY ONE STUDY WOULD HAVE CAPTURED THAT AND USED LARGE SKAND NAVIAN DATABASES. REASON WE CAN DEFINITIVELY STATE ABOUT OVARIAN CANCER IS 21 STUDIES AND [INDISCERNIBLE] HAVE BEEN -- IT IS A P BODY OF LITERATURE THING AND ALSO I THINK OTHER CRITICAL THING THAT IS COMPLICATED CARDIOVASCULAR DISEASE DISCOVERY AND AUTO IMMUNE DISEASE DISCOVERY AND OTHER TYPES OF DISCOVER JI IS WE NEED TO REMEMBER IT IS IN THE SAME FOOTPRINT TO FIND ENDOMETRIOSIS AND ORE VARIAN CANCER. ENDOMETRIAL CANCER IS INTERESTING WHEN YOU LOOK AT LITERATURE THERE IS HETERO-JENAETY THAT IS DRIVEN BY IF YOU LOOK AT STUDIES BEFORE ENDO MEETTRIOSIS AND END DOE MEETTRIAL CANCER ARE DIAGNOSED AT SAME TIME 4 INCREASE. -- STUDIES HAD TO BE DIAGNOSED SEVERAL YEARS BEFORE ENDO MEETTRIOSIS CANCER -- THEN YOU SEE NULL. THERE IS BIAS HERE ANOTHER EXAMPLE OF THIS IS CERVICAL CANCER FOR STUDIES FOR VERY STRONG PROTECTIVE EFFECTS. SO WE DON'T HAVE A HYPOTHESIS WHY ENDOMEET TRIO SIS WOULD -- CERVICAL CANCER GETS PREVENTED IF IF YOU PICK UP DYSPLASIA AND IF YOU HAVE ROUTINE CARE AND IF YOU ARE DIAGNOSED WITH ENDO MEETTRIOSIS AND YOU HAVE ROUTINE CARE AND HINTS THAT SCREAM AT US AND WORRIED ABOUT DIAGNOSTIC BIAS AND WE HAVE TO FIGURE OUT FEAR OF THIS ISSUE. >> FIRST OF ALL, THANK YOU. WHEN I LISTEN TO THIS, I WORRY ABOUT THE ONE -- WHAT WE DON'T KNOW ABOUT THE DENOMINATOR. >> STACEY MISSMER: YUP. >> DIAGNOSIS AS WELL AS LIFE COURSE OF THE PROBLEM AND SOME CONCERNS ABOUT BOTH SENSITIVITY AND SPECIFICITY. WHAT I'M REALLY THINKING ABOUT IS DIAGNOSIS IN EARLY ADOLESCENCE. THERE IS LOTS OF STUFF THAT ENTERS INTO THE CLINIC IT THAT IS DIS-MUIR NEURIA AND PELVIC PAIN AND HOW DO WE DO THAT DIAGNOSIS EARLY STIGMA WITH EARLY DIAGNOSIS AND YOU NEED SURGERY IN EARLY ADOLESCENCE TO DIAGNOSE. THERE HAVE BEEN -- YOU USED TO SEE YOUNG PEOPLE WITH MULTIPLE LAP AROSCOPIES FOR PELVIC PAIN I WONDER WHAT CURRENT THINKING IS AROUND EARLY DIAGNOSIS? YOU CAN IMAGINE THAT TIME TO DIAGNOSE IS NOT NECESSARILY THAT EARLY ON PEOPLE DIDN'T KNOW WHAT TO DO. IT IS JUST THERE WERE LIMITED MODALITIES MAKING DEFINITIVE DIAGNOSIS CARRIES RISKS AND CONCERNS AND THERE ARE MEDICAL MANAGEMENT AND CERTAINLY WITHIN ACOG WE HAVE BEEN SAYING USE SUPPRESSION. >> STACEY MISSMER: RIGHT. >> CERTAINLY FOR EARLY ADOLESCENCE I WANTED TO GET A SENSE OF -- >> STACEY MISSMER: ABSOLUTELY. THERE ARE HEATED DEBATES. ONE THING THAT I HAVE SEEN AT PROFESSIONAL MEETINGS, PEOPLE YELLING AT EACH OTHER OVER IS THE ADOLESCENCE DIAGNOSIS AND WHETHER IT IS BENEFICIAL OR HARMFUL. I THINK WE MAKE -- WE KNOW EXPERIENCING SYMPTOMS FOR SEVEN YEARS WITHOUT APPROPRIATE REMEDIATION YOU GET TO SURGICAL DIAGNOSIS AT THAT POINT THAT IN AND OF ITSELF MUST BE BENEFICIAL. ISSUE WHETHER ADOLESCENT IN PARTICULAR NEEDS A LABEL AND WHETHER SURGERY SHOULD BE PART OF THE MIX OR IF WE NEED TO CREATE ALGORITHM THAT SELECTS THOSE WHO WOULD MOST LIKELY BENEFIT FROM SURGERY VERSUS THOSE THAT WOULD MOST LIKELY BENEFIT FROM EMPIRIC TREATMENT. MOST OF CERTAINLY OUR COLLEAGUES ARE CHIEF OF GYNECOLOGY AT BOTON HOSPITAL AND INTERNATIONAL PELVIC PAIN SOCIETY IS MORE PAIN MANAGEMENT APPROACH WOULD ARGUE STANDARD OF CARE TREATING SYMPTOMS AND SYMPTOM REMEDIATION AT THIS POINT IN TIME WE DON'T HAVE EVIDENCE THAT HAVING DEFINITIVE DIAGNOSIS AND EXCISING LESION WHICH WOULD GO HAND IN HAND IS DOING BENEFIT OVER ORAL CONTRACEPTIVE REMEDIAITION THAT IS WORKING. >> ALL RIGHT. THANK YOU. >> DIANA BIANCHI: LET'S THANK DR. MISSMER. >> THANK 4 AN OUTSTANDING TALK. THERE IS SO MANY DIRECTIONS WE CAN FURTHER PURSUE RESEARCH. YOU CAN TELL BY THE QUESTIONS. FOR THOSE THAT ARE NEW TO COUNCIL, WE NOW INCLUDE A VERY IMPORTANT SECTION CALLED VOICE OF THE PARTICIPANT. THIS IS BECAUSE WE CAN HEAR DR. MISSMER'S VERY ELOQUENT DESCRIPTION OF THE NEED FOR THE RESEARCH, BUT IT IS SO IMPORTANT TO HEAR DIRECTLY FROM SOMEONE WHO HAS BEEN EFFECTED BY, IN THIS CASE, ENDOMETRIOSIS. WE ARE VERY GRATEFUL THAT TODAY ERICA HAS AGREED TO COME TOT NICHD COUNCIL AND TELL US A LITTLE ABOUT HER OWN PERSONAL EXPERIENCES. THANK YOU VERY MUCH, ERICA. >> AUDIENCE: MRAUDZ. >> THANKS FOR COMING AS ALWAYS. >> ERICA RUSSELL: HELLO. IT IS AN HONOR TO BE ABLE TO SPEAK WITH YOU ALL TODAY. I APPRECIATE THE OPPORTUNITY AND I HOPE TO SHED LIGHT ON THE ISSUE OF ENDOMETRIOSIS FROM MY PERSONAL EXPERIENCE. FOR ME TO TELL MY STORY ABOUT ENDOMETRIOSIS, I FORCED MYSELF BACK TO RECALL A TIME WHEN ENDOMETRIOSIS INTERRUPTED MY DAILY LIFE AND IT IS A TIME I DON'T READILY REMEMBER TO EXPLAINLY HEALTH HISTORY IS TO HAVE DEEPLY -- THESE ARE TIMES I WOULD RATHER FORGET. ENDOMETRIOSIS BECAME SOMETHING LINKED TO ALL ASPECTS OF MY LIFE AND WAS HOWEVER A TOPIC I ALWAYS HATED TALKING ABOUT. I'M SLOW TO ADMIT PAIN, ITS EFFECT ON ME, AND TO TALK ABOUT HOW I'M FEELING. I'M SLOWER TO ACCEPT HELP. IT IS ODD FOR ME TO HEAR 10% OF WOMEN HAVE ENDOMETRIOSIS YET SUCH A LACK OF UNDERSTANDING AND INFORMATION ON THIS TOPIC MAYBE BECAUSE PERIOD PAIN IS NORMAL PART OF WOMANHOOD AND TO COMPLAIN IS OFTEN BRUSHED OFF AS A WEAKNESS OR EXCUSE. YEARS OF ENDOMETRIOSIS HAVE BEEN LONELY DEPRESSING AND DOWN-RIGHT FRIGHTENING SOMETIMES THOSE THAT KNOW ME SEE WHEN MY FACE IS ETCHED IN PAIN AND THOSE THAT DON'T HAVE NO IDEA HOW MUCH EFFORT KEEPING IT ALL TOGETHER TAKES. MY PERIOD PERIOD CAME SEEMINGLY LATE WHEN I WAS 17 DURING JUNIOR YEAR OF HIGH SCHOOL IN 1999. REACTION MY PARENTS HAD WAS NOT ONE THAT I EXPECTED. THEY SEEMED EXCITED AND PROUD OF THIS APPARENT SIGN OF GROWING UP. I FELT PAIN. MONTHS WENT ON EACH TIME IT WAS THE SAME FETAL POSITION AND NO WORK OR SCHOOL FOR A FEW DAYS AND DESPERATE ATTACHMENT TO MY HEATING PAD AND STATE OF ABSOLUTE CONFUSION AND TOOK MOOID OL AND EVERY OVER THE COUNTER MEDICATION AVAILABLE AND IT DIDN'T DO MUCH. ANY TIME I BROUGHT IT UP THE RESPONSE IS PREDICTABLE IT IS JUST CRAMPS AND WILL GO AWAY. THIS IS NORMAL. I NEVER BELIEVED IT AND DIDN'T SEE FEMALES CLOSE TO ME CURLED UP ON THE BATHROOM FLOOR PATTERN OF PERIOD AND PAIN CONTINUED. ODD THING ABOUT PAIN IS YOU GET USED TO T THERE IS A CYCLE TO IT. PREP SO YOU HAVE EVERYTHING YOU NEED WHEN YOU GO DOWN. LIE VERY STILL GET BACK UP AFTER A FEW DAYS AND TRY TO CATCH UP. ANY FEELING GOOD DAY IS A DAY TO TAKE ADVANTAGE OF. QUICKLY ACCOMPLISH ALL NECESSARY TASKS AND SOCIALIZE AND HAVE FUN. AT THIS POINT IN LIFE, PAIN WASN'T COMPLETELY TAKING OVER EVERYTHING. I TOOK A GAP YEAR IN COLLEGE WORKING AT AN ORPHANAGE AND DAYCARE CENTER FOR AT RISK IN HON DURAS. I MET MANUEL A TODDLER THAT WOULD BECOME A SON TO ME. THIS PART OF MY STORY MIGHT SEEM IRRELEVANT WHEN COMES TO ENDO MEETTRIOSIS IT STABILIZED ME COUNTLESS CONVERSATIONS REGARDING FERTILITY IN THE COMING YEARS I WAS SURE I CAN LOVE ANY CHILD FERTILITY IS IRRELEVANT HEALTH IS NOT. -- WHEN I CAME BACK TO THE STATES TO FINISH COLLEGE MY SYMPTOMS IN PAIN INCREASING. I WAS 21 AT THIS TIME. I DECIDED TO GO TO THE MEDICAL CENTER TO FIGURE OUT WHAT WAS GOING ON. LIVING IN A SMALL TOWN MAKES LIVES EASILY CONNECTED. MY DOCTOR WAS A CLOSE FRIEND'S FATHER. THEREFORE, A VISIT LIKE THIS WAS A LITTLE BIT AWKWARD FOR ME. I TRUSTED HIM AND HIS EXPERTISE. HE IS TO THIS DAY ALWAYS AVAILABLE TO CONSULT WITH AND PROVIDES A LIST [AUDIO CUT OUT] I WAS ADVISED TO STAY OFF MY FEET AND DECREASE ACTIVITY FOR SEVERAL MONTHS. I RESTARTED BIRTH CONTROL AND CONTINUED TO SEE THIS OBGYN FOR ABOUT A YEAR. MY PARTNER AND I MOVED TOWNS AND I FOUND A NEW OBYGN THAT THAT PRESCRIBED LUPRON AND DEPO PRIFERA. LUPRON WAS THE DEVIL AND I OPTED FOR DEPO WHICH TURNED ME TO A ROBOT IT HELPED REDUCE PAINS AND SYMPTOMS BUT CHANGED MY MOOD DRASTICALLY. I WORKED FULL-TIME TO SUPPORT US WHILE MY PARTNER WAS IN SCHOOL DAYS OF PAIN OR DAYS TO WORK THROUGH THERE WAS NO OTHER CHOICE I REMEMBER HER BEGGING ME NOT TO TAKE THE ROBOT SHOT BUT I WAS HOOKED I COULDN'T STAND OR WORK OR KEEP US AFLOAT FOO FINANCIALLY -- DIMINISHED AND REGULAR DUTIES WERE A STRUGGLE I SPENT A LOT OF TIME IN BED THAT YEAR MY RELATIONSHIP SUFFERED AND OUR 5-YEAR PARTNERSHIP ENDED. IT WAS BEST TO MOVE ON. I DECIDED TO PURSUE A CAREER IN BILINGUAL EDUCATION IN VIRGINIA. MY LITTLE AUNTIE GEORGE EVEN CAME THROUGH IN A BIG WAY IN MY LIFE WHEN I MOVED HERE IN 2006. SHE HELPED ME GET ESTABLISHED AND REFUSED TO ACCEPT LEVELS OF PAIN I WAS DEALING WITH. DR. HAM ELFROM MICHIGAN SUPPORTED ME DURING THIS TRANSITION WITH DEPO XANAX AND LECHLO PRO WHILE I GOT MYSELF BACK ON MY FEET. IT WAS THEN THAT I FOUND OUT MY AUNTIE TOO HAD ENDOMETRIOSIS PAIRED WITH FIBROID TUMORS AND TRIED BIRTH CONTROL WITH LITTLE TO NO SUCCESS AND LED TO A FULL HYSTERECTOMY FOR HER AT AGE OF 27 AT AGE OF 1972. SURGERY SOLVED HER PAIN AND SHE HASN'T HAD COMPLICATIONS SINCE THAT SHE ATTRIBUTES TO ENDOMEETTRIOSIS AFTER THIS SHE RETIRED AS SUCCESSFUL FULL-TIME CAREER AT WASHINGTON SPEAKERS BUREAU SHE IS A HUGE ADVOCATE FOR ME TO THIS DAY. SHE WILL MOVE MOUNTAINS AND KNOCK ANYONE DOWN THAT SLOWS THE PROGRESS OF ME GETTING HEALTHCARE I NEED. SHE SAT ON THE PHONE FOR HOURS AND SEARCHED THE INTERNET RELENTLESSLY AND SHOWS UP WHEN THINGS GET COMPLICATED. IN 2007 I BEGAN TO SEARCH FOR DOCTORS IN THE DC AREA. MAINLY LOOKING FOR OBGYNS WHO WERE YOUNG AND MAY HAVE HAD THE MOST RECENT UNDERSTANDING OF ENDOMETRIOSIS AND TRIED A FEW BEFORE KOCHLING ACROSS [INDISCERNIBLE] AT GEORGE TOWN UNIVERSITY HOSPITAL SHE WAS KIND AND DRIVEN AND ATTENTIVE AT TRYING TO FIND ME RELIEF. I TRIED MOST FORMS OF BIRTH CONTROL I WAS ATTACHED TO DEPEE AND WE TRIED EVERY TREATMENT AVAILABLE ANYWAY FOR NEXT TWO YEARS SONNO GRAMS ULTRASOUNDS AND MRIS AND MORE DR. WAS CLEVER AND CONVINCING I WAS DRIVEN BY HOPE AND FACT MY LIFE WAS BEING SLEDDED BY SYMPTOMS AND PAIN AND LONGED FOR NO. NORMALITY AND SHE SAW ME AS HER LAST PATIENT OF THE DAY TO SPEND TIME SHE NEEDED WITH ME COMING TO END OF MY DAY MEANT I DIDN'T HAVE TO TAKE A DAY OFF FROM TEACHING I LIVED ON VICODIN DURING BAD DAYS I'M NOT FOND OF PAIN KILLERS WHEN PAIN REACHES A 10 FOR ME I PASS OUT. IF PAIN LEVELS CLIMB OR JUMP TO AN 8 IT IS TIME FOR MEDS. NARCOTICS WERE A LAST RHO RESORT AND FEARED BECOMIN DEPENDENT IT WAS GNAWING PAIN WITH TWISTING AND PINCHING SENSATION ON LOWER PELVIC REGION OVER RIGHT OVARY DEEP PAIN AND HEAT IN LOWER PELVIS AND ANTICIPATION OF PAIN BROUGHT ON ANXIETY I WOULD PREP FOR THE NEXT WAVE TO SLOW ME DOWN. THREE DAYS DOWN AND WOI BE EXHAUSTED LIVING ON LOW DOSES OF OPIOIDS AND CALLING A DOCTOR. VISITS TO THE ER WERE COMMON DURING ENDOYEARS AND MET WITH SIMILAR RESPONSES. FIRST SOMETHING TO HE'S THE PAIN AND PROBABLY MORPHINE AND VAGINAL CHECKS THAT WERE EXCRUCIATING THEY MADE ME FEAR I WOULD MURDER THE POOR DOCTOR AND WORKUP ALWAYS CLEAR IN THE END AND PRESCRIPTION FOR VICODIN AND STANDARDIZED PRINT OUT ABOUT PELVIC PAIN WITH DISCHARGE OF PAPERS DR. MASLOW KEPT ME SANE DURING THIS TIME EXPLAINING IF WE WENT THROUGH ALL OF THE STEPS HYSTERECTOMY WOULD COME IF NEEDED MAYBE WE COULD FIND A BETTER SOLUTION. NOTHING WORKED MY MENTAL HEALTH WAS FADING AS PAIN BECAME A NEAR DAILY REALITY. EXCEPT FROM ANY 2008 JOURNAL READS -- I FOUGHT THE SYSTEM 7 YEARS IT RAN ME THIN IN A WAY I WISH THE PAIN WOULD COME IN AND CLOUD MY BRAIN I WOULDN'T FEEL THIS HATE OR WONDER THIS HAS SUNK ME I PREFER DEATH. I CAN'T SEE FREEDOM IN A NORMAL LIFE WITHOUT MEDICATION IN A RELATIONSHIP HEALTHY AND ACTIVE SO I PLEADED WITH DR. MAZ AND SHE PLEADED WITH ME MORE TREATMENTS I'M STILL SO YOUNG NO ONE WILL TAKE IT ON. OUR OPTIONS MARINA IUD CONTINUE WITH DEPO AND USE LUP RON TO DETERMINE WHETHER TO KEEP OR REMOVE MY OVARYIES. I WENT TO A DOCTOR TO HAVE MARINA IUD IMPLANTED TWICE IN 2008. PAIN WAS TOO MUCH FAINTED ON FIRST ATTEMPT WAKING UP TO UNEXPLAINED BLOOD ON TABLE AND FLOOR AND GIVEN MEDICATION TO SOFRP S- CERVIX TO TRY AGAIN A FEW WEEKS LATER NO LUCK AND MONTH MONEY WASTED BY DECEMBER 2008 I WAS TAKING DEPO AT 10 WEEKS APART AND LOSING MULTIPLE DAYS OF WORK AND IN EXTREME PAIN. OPTIONS FOR A YOUNG FEMALE FOR LIMITED I COULD YELL ABOUT IT ALL I WANTED BUT WASN'T A DOCTOR AROUND TO PERFORM A HISTRECT ME ON ME REGARDLESS OF MY FERTILITY OR THAT I WAS FULL ADULT. -- LAST RESORT FOR SOMEONE SO YOUNG. HYSTERECTOMY WASN'T NECESSARILY GOING TO CURE THE PAIN ANYWAY MY POTENTIAL FOR CHILDREN IN THE FUTURE SEEMED TO TAKE PRECEDENCE OVER MY HEALTH. I HAD NO PLANS FOR KIDS AND MORE IMPORTANTLY DIDN'T HAVE THE ABILITY TO CARE FOR A CHILD I COULDN'T TAKE CARE OF MYSELF ON MY OWN AT THIS POINT. SEEMED THE THOUGHT WAS SOME DAY SOMEONE WOULD COME INTO MY LIFE AND THEN I WOULD WANT KIDS HERE IS ONE FLAW WITH THAT THOUGHT IT IS NEARLY IMPOSSIBLE TO MAINTAIN RELATIONSHIPS LET ALONE START A NEW ONE WHILE SICK. ANOTHER FLAW WHY WOULD MY PARTNER AND I WANT THIS SNI CAN'T WANT TO PASS ON THESE KINDS OF GENES OR WANT A CHILD TO SUFFER LIKE I DID. BY APRIL 2009, DR. MAZ LOM DEUCE EXHAUSTED HER OPTIONS AND I WAS A MESS. SHE WAS RELUCTANT ABOUT THE HYSTERECTOMY AND I REMAINED CONSISTENT ON MY CHOICE ABOUT FERTILITY. WE FOLLOWED THE PLAN. APRIL 17 SHE PERFORMED A HYSTERECTOMY SPARING MY OVARIES. THAT MORNING GO TO SURGY WAS ONE OF THE FIRST TIMES I FELT JOY AND HOPE AND A VERY LONG TIME. I REMEMBER SMILING AFTER SURGERY THERE WAS A KWIE INSIDE MY BODY STOPPED SCREAMING RECOVERY WASN'T EASY I DEVELOPED INFECTION HORMONES WILD AND GASTROINTESTINAL ISSUES BEGAN. DR. MAZ HAD ME GO TO SEVERAL DOCTORS BY JULY 2009 COLONOSCOPY UPPER ENDOSCOPY BLADDER AND URINARY TRACT AND NO ENDOMETRIOSIS WAS FOUND I WAS ADVISED TO STAY AWAY FROM ANTI-INFLAMMATORIES PERMANENTLY AND POSSIBILITY I DEVELOPED CROHN'S DISEASE I BEGAN SEEING GASTROENTOLOGIST ON REGULAR BASIS ANOTHER YEAR PAST JUNE 2010 DEBILITATING PAIN WAS BACK AND PERSISTED CONTINUOUSLY FOR TWO WEEKS. ULTRASOUND CAME BACK CLEAR RECOMMENDED PAIN IMAGINE AJMENT THERAPY COUNSELING AND PHYSICAL THERAPY AND GOING BACK ON DEPO I TRIED PT PELVIC FLOOR AND MIOFASHAL RELEASE. 2011 WAYS IN STATE OF EXHAUSTION WITHDRAW FROM PEOPLE. I WENT BACK TO DR. MAZ AFTER DISCOVERING ANOTHER DOCTOR WHO WOULD BE HAPPY TO AGAIN SURGICALLY REMOVE ANY ENDOMETRIAL GROWTH. THIS SHOULD HAVE BEEN WARNING SIGN TO ME DR. MAZ HAD BEEN CLEAR 600 TO 80% OF THE TIME YOU GO BACK IN NOTHING IS FOUND. ANOTHER SURGERY AND TAKES TIME TO RECOVER AND ANOTHER FINANCIAL HIT. I WENT THROUGH WITH IT ANYWAY. BEFORE MAZ WAS RIGHT. I WAS MISDIAGNOSED WITH INTERSTITIAL SIFTITIS THAT WAS A SIMPLE BLADDER INFECTION AFTER BEING CLEARED IN 2 THOUGH YOU 10 BY UROLOGIST I WAS EMOTIONALLY AND PHYSICALLY RAW AT THIS POINT AND THEN I DECIDED TO TAKE A BREAK TO SEE IF THE BODY COULD HEAL. I HAD NO MORE ENERGY OR MONEY. THERE WAS NO INDICATION WE WOULD FIND A SOLUTION. I SINCE SOUGHTALITY TERNTY THERAPIES INCLUDING ACUPUNCTURE AND HERBAL FORMULAS I USE TODAY TO EASE CYCLES OF PELVIC PAIN. ACUPUNCTURE PROVIDED ME WAY TO NAVIGATE HURDLES AND STRESS THAT COMES WITH FIGHTING LONG-TERM PAIN. LAST FEW MONTHS I HAD ONE MORE PELVIC PAIN SCARE ESTABLISHING YOURSELF AS NEW PATIENT AND EXPLAINING THIS WHOLE SAGA OF YOUR HEALTH HISTORY IS EXHAUSTING AND TIME CONSUMING AND KNEW I NEEDED TO SEE A DOCTOR AND NEEDED SOMEONE I TRUSTED AND COULD BREAK IT DOWN FOR ME. I RECONNECTED WITH DR. MAZ. THANKFULLY THINGS HAVE RESOLVED AND I RETURNED TO THE FREEDOM OF A HEALTHIER LIFE LIKE OTHER WOMEN WITH ENDOMETRIOSIS I HAD POST CARE HEALTH ISSUES HALF OF MY LIFE ENDURED INVASIVE TESTING AND DOCTORS THAT CHASED THE LATEST SYMPTOMS I MUST SAY THIS WHOLE PROCESS HAS BEEN PRETTY EXHAUSTING. I DON'T THINK MY STORY IS MUCH TO TALK ABOUT. I KNOW PEOPLE WHO SUFFER WITH MUCH WORSE. THE IMPACT OF A LONG-STANDING ILLNESS ON ME HAS BEEN PROFOUND. I LIVED IN PAIN FOR A DECADE PAIN THAT COMES IN BRIGHT FROM MY LIPS TO MY TOES AND FADES TO ADULT CONSTANT AND SHARP PAIN THAT MAKES YOU MOWN AND WAKE UP SUDDENLY AND HORMONE SHIFTS THAT TURN MY BODY TO A RAGING BEAST. PAIN CHANGES YOU. HOW DID ENDOMETRIOSIS EFFECT ME? STOLE MY JOY AND LIMITED BY AMBITIONS GOAL WAS TO STAY UPRIGHT TO MANAGE MY SYMPTOMS PEOPLE DIDN'T CONSIDER I WANTED FLY AND BE AMAZING. PERSONAL SIDE I HAD RELATIONSHIPS FADE AWAY. FRIENDS YELLED AND CRIED I NEEDED TO FIND A SOLUTION TO GET HELP. WITH MY CLOSEST FRIENDS I PUSHED THEM AWAY. I'M SLOW TO SHARE ALL OF THIS. I COULDN'T MAKE PLANS WITH PEOPLE AS I WOULD NOT KNOW HOW I WOULD BE FEELING. UPCOMING CAMPING TRIPS? NO. DINNER, NOT SURE. CONCERTS PROBABLY NOT BETTER. BETTER NOT GET A TICKET. I SACRIFICED MY HEALTH TO SHOW IT FOR THE PEOPLE IN MY WORLD I DON'T WANT TO BE SEEN AS SOMEONE TO BE TAKEN CARE OF BUT A FRIEND A SISTER A DAUGHTER AND GIRLFRIEND. I HAVE BEEN ON MY OWN SINCE I WAS 17 YEARS OLD THAT MEANT MANAGING FINANCIAL STRESS OF LONG TERM ILLNESS AS WELL AS BEING OWN ADVOCATE BEING ON DEFENSE AND OFFENSE ALL THE TIME I'M MY BACKUP PLAN OUT OF POCKET MAXIMUM HAS BEEN MET MOST YEARS AND LEARNED TO RELY ON FRIENDS REPLENISHING FOOD SUPPLY WALKING DOG PICKING ME UP FROM PROCEDURES AND RIDES HOME FROM ER. I USE ALL MY SICK DAYS AND THEREFORE HAVE NO TIME OFF FOR COMPLICATIONS OF LIFE. I TAKE DAYS WITHOUT PAY AND TIMES I COULDN'T AFFORD MY LIFE AND HAD TO MOVE IN WITH OTHERS AND MY AUNTIE BEING ONE OF THEM. THIS WAS DURING COMPLETE CLANS OF MY HEALTH. MY ENTIRE JOB IS TAKING CARE OF PEOPLE. THE PAIN AND SYMPTOMS INTERRUPTED LARGE CHUNKS OF MY LIFE. I BECAME A SHADOW OF MYSELF. NO MATTER HOW HEALTHY I LIVE AND CLOSELY I FOLLOW DOCTOR'S ADVICE. IT SEEMED IT DIDN'T MATTER. I COULDN'T CONTROL WHAT WAS HAPPENING TO MY BODY. THERE WAS TIMES THIS FACT TOOK ME TO THE BRINK OF SUICIDE. I WAS RAISED TO BE A COMPETENT AND PRODUCTIVE CITIZEN. IT WAS DOWNRIGHT EMBARRASSING TO LOSE THAT KIND OF FIGHT. I TEND TO COMPARTMENTALIZE HOW I FEEL AND MINIMIZING IT IS A REQUIREMENT TO REDUCE WORRY FOR THOSE AROUND ME. WHEN THINGS GOT BAD, I WAS UNABLE TO FILTER THINGS. I CAN'T HELP THOSE I LOVE THROUGH THE UNKNOWNS AND THEIR INABILITY TO FIX IT IS VERY HARD ON THEM. AT TIMES, I CAN'T TAKE ON THEIR FEELINGS. IN ORDER TO AVOID SINKING INTO NEGATIVITY, I TURN MY BRAIN OFF TO WHAT IS NORMAL AND WHAT I QUICKLY ACCEPT AS NORMAL IS OFTEN ANYTHING BUT. WHEN I FEEL WELL I FORGET ABOUT MY STRUGGLES AND MOVE FORWARD AND IF ASKED I ALWAYS REPLY I'M FINE. HOWEVER THE GOOD NEWS IN ALL OF THIS IS I'M INCREDIBLY STUBBORN AND HAVE BEEN SURROUNDED BY REALLY GOOD PEOPLE AND MY FAMILY IS A UNIQUE BLEND BOTH RELATED AND NOT THAT WOULD DROP EVERYTHING FOR ME AS I DO THEM I AM AWESOME TO HAVE BOTH SIDES OF FAMILY WITH HYSTERECTOMIES IN 20S AND 30S DUE TO ENDOMETRIOSIS I'M CLOSE TO THEM THIS WASN'T A TOPIC THAT CAME UP UNTIL MY STRUGGLE WITH PAIN BECAME DEBILL TATING. IT DOESN'T SURPRISE ME. THESE ARE NOT THINGS WE TALK ABOUT. THANKFULLY I HAVE NEVER BEEN FIRED BECAUSE I HAVE BEEN MET BY KINDNESS OF MY BOSSES THAT LET ME SLEEP ON MY BREAK AND UNDERSTAND THAT HEALTH AND SITUATIONS CHANGE AND RALLY AROUND SUPPORT OF ME DURING HARD TIMES AND ABLE TO HELP MY -- DECLINE WITH DEMENTIA WHEN I WAS MOST ILL AND COMPLETE COLLEGE AND NOW WENT ON TO FINISH MY MASTERS AFTER MY HYSTERECTOMY REMAINED IN TEACHING AND AWARDED TEACHER OF THE YEAR FOR ALL OF THE COUNTY IN ARLINGTON. I LIVE DEBT FREE WITH $10,000 IN THE BANK IN CASE ANY HEALTH ISSUES RETURN. THIS IS SIMPLY MY MAXIMUM OUT OF POCKET FOR IN AND OUT OF NETWORK COVERAGE. THIS IS NOTHING CRAZY I HAVE BEEN ABLE TO CONTINUE VOLUNTEERING IN HON DURAS DURING THE SUMMERS FOR MORE THAN 15 YEARS I WILL HEAD DOWN IN A FEW WEEKS TO SEE MY KIDS MANUEL HAS GROWN UP. HE IS 19. I'M SORRY. HE LIVES ON HIS OWN. WE ARE VERY CLOSE AND I'M GRATEFUL AND PROUD I CAN SUPPORT HIM AND THAT I CAN BE A GOOD MOM. I TEACH ESL TO MIDDLE SCHOOL IMMIGRANTS FROM AROUND THE WORLD WHO COME FROM ALL KINDS OF SITUATIONS WHEN THEY BRING THEM TO ME I'M THEIR BIGGEST FAN. SOME OF THE THINGS I IMAGINE I ACCOMPLISH WHILE SICK. MOST COME AROUND BECAUSE OF CHANGE IN HEALTH. I REFLECT THESE ARE THINGS THAT MIGHT HELP DANGER PARAMETERS WHEN DOCTORS CLEARLY STATED HOW TO PREPARE. IF THIS, GO TO THE ER. IF THAT, COME TO THE DOCTOR. IF NOT WAIT AND SEE AND CALL. IF THESE IT IS ALL NORMAL IT SAVES TIME, STRESS, AND MONEY. AT HOME TREATMENT AND ABILITY TO GIVE MYSELF SHOTS SAVED TIME AND A COPAY OVERALL PLAN MAZ'S HAD A LIST THAT SAVED TIME AND COMMUNICATED OUR SHORT AND LONG TERM GOALS KNOWING THE BEST WAY TO CONTACT A DOCTOR, DOCTORS THAT TAKE TIME TO WRITE OUT NOTES WHAT THEY TOLD YOU. I KNOW DOCTORS ARE OVERBOOKED BUT HELPS WITH ONSLAUGHT OF INFORMATION AND UNFAMILIAR TERMS APPOINTMENTS WERE SHORT AND I WAS STUCK WITH GOOGLE TO FIGURE OUT WHAT THE DOCTORS HAD BEEN REFERRING TO. THESE DETAILED NOTES HELPED ME WITH THE PROCESS. ALTERNATIVE THERAPY HEALTHY LIFESTYLES LIFELONG VEGETARIAN AND HIGHLY ACTIVE THOSE THINGS FALL AWAY WHEN YOU ARE SICK. COPING STRATEGIES POSITIVE SELF-TALK AND SECOND OPINIONS. A FEW RECOMMENDATIONS THAT COME TO MIND ARE THE FOLLOWING HAVING A PATIENT ADVOCATE SO MUCH TO NAVIGATE A PERSONALIZED APPROACH WOULD SURELY HELP. KEEPING A PATIENT HEALTH JOURNAL TO BE BROUGHT TO EVERY APPOINTMENT TO TELL THE CURRENT STORY AND STORY OVERTIME. TREATMENT AND SYMPTOMS CHANGE THUS CHANGING THE STORY. COUNSELING AND UNDERSTANDING BY DOCTORS THAT EXAMS DO HURT. TALK FIRST. IT IS NOT EASY TO THINK WHILE IN PAIN. BE INVASIVE AND ASK ALL OF THE QUESTIONS BUT TAKE TIME TO LISTEN. TREATMENT PLAN IN THE ER FOR PATIENTS WITH ENDOMEETTRIOSIS ARE SYMPTOMS SIMILAR TO. FINDING TIME FOR PATIENTS IF IN PAIN. ENDOMETRIOSIS IS NOT TREATED AS URGENT PROBLEM WHAT CAN STUDENTS DO WHEN THINGS GET BAD. FMLA. HOW ABOUT TREATMENT OPTIONS? IN CONCLUSION I WANT TO SAY THANK YOU. I'M FOREVER GRATEFUL TO DR. MAZ FOR HER DEDICATION TO PATIENT ADVOCACY SHE PROVIDES TO PATIENTS AND THROUGHOUT HER CARE OVER THE YEARS THANK YOU FOR YOUR PASSION AND ZEAL AND RESEARCHING ENDOMETRIOSIS AND LISA HAL VERSON FOR SUPPORT AND COMMITMENT TO WOMEN'S HEALTH CARE AND THANK YOU TO KARNDIS FOR YOUR HEALTH AND [INDISCERNIBLE] FOR CHOOSING THIS TOPIC AND EVERYONE ELSE WHO MADE THIS OPPORTUNITY POSSIBLE AND THANKS FOR LISTENING TO MY STORY AND ADVANCING RESEARCH, INNOVATION, AND CARE. >> AUDIENCE: [APPLAUSE]. >> DIANA BIANCHI: THANK YOU, ERICA. THE IT TAKE AS I HUGE AMOUNT OF COURAGE TO GO INTO SOME OF THE MOST PERSONAL AND PAINFUL AND INTIMATE DETAILS OF YOUR LIFE. YOU KNOW, YOUR WORDS REALLY INSPIRE EVERYONE IN THIS ROOM. PEOPLE ARE WATCHING AROUND THE COUNTRY AND WORLD WHO FOR ALL WE KNOW, THEY MAY HAVE THE ANSWER TO THE PROBLEM OR THAT YOU MAY HAVE INSPIRED THEM TO EMBARK UPON A CAREER IN RESEARCH THAT WILL ULTIMATELY LEAD TO THE SOLUTION. YOU YOU KNOW, WE GREATLY APPRECIATE THE TIME YOU SPEND IN PREPARING YOUR STATEMENT AND ALSO THE WILLINGNESS TO COME UP AND BE SO PERSONAL ABOUT YOUR STORY. WE REALLY GIVE OUR HEART FELT THANKS. WE HAVE ONE LAST AGENDA BEFORE WE BREAK FOR LUNCH. DELLA WILL PRESENT THE CONCEPT CLEARANCE REVIEW. WE ARE MORE THAN -- WE ARE ACTUALLY EXACTLY ON TIME. WE HAVE TIME. I CAN'T BELIEVE IT WITH EVERYTHING THAT HAS HAPPENED TO KIND OF THROW US OFF SCHEDULE, WE ARE REMARKABLY ON TIME. WE WILL NOW MOVE TO THE CONCEPT CLEARANCE AND WE HAVE TIME FOR DISCUSSION. >> DELLA HANN: OKAY. THANK YOU VERY MUCH. WE HAVE EIGHT CONCEPTS TO PRESENT TO YOU TODAY. FOR EACH CONCEPT, I WILL ASK THE STAFF TO JOIN US AT THE TABLE AND PROVIDE A BRIEF OVERVIEW OF THE INITIATIVE AND ASK COUNCIL FOR ANY DISCUSSION REGARDING THE CONCEPT. AT THE CONCLUSION OF THE DISCUSSION FOR EACH CONCEPT I WILL ASK COUNCIL MEMBERS WHETHER THEY CONQUER OR NOT. OUR FIRST WILL BE DR. LEWD OPOLLO DESCRIBING FERTILITY AND [INDISCERNIBLE] FOR PATIENTS WITH PREVIOUSLY CONCLUDED REPRODUCTION. >> DR. TAMAN IS ILL THIS MORNING. I'M PRESENTING FOR HER. PROGRAM SEEKS COUNCIL APPROVAL FOR INITIATIVE TITLE FERTILITY AND FERTILITY PRESERVATION FOR PATIENTS AND DISEASES THAT PREVIOUSLY CONCLUDED REPRODUCTION. THANKS TO ADVENT OF SCREENING PROTOCOLS AND TREATMENT OPTIONS CHILDREN WITH DEBILITATING -- THEIR CONDITION AND/OR CONSEQUENCES OF ITS TREATMENT HAVE OFTEN SEVERELY COMPROMISED REPRODUCTIVE HEALTH AND FERTILITY THAT CAN BE DEVASTATING LOSS. THIS IS A NEW PROBLEM REPRODUCTIVE HEALTH FERTILITY PRESERVATION AND OPTIONS FOR PATIENTS BORN IN CHRONIC DISEASES WITH REPRODUCTION ARE UNDER STUDY. PURPOSE OF RFA IS TO ENCOURAGE STUDIES ON REPRODUCTIVE HEALTH FERTILITY FERTILITY PRESERVATION IN TREATMENT OPTIONS OF PATIENTS BORN WITH SERIOUS CHRONIC CONDITION WHERE TO ADULTHOOD WHERE THEY CAN CONSIDER OPTIONS. >> DELLA HANN: GREAT. THANK YOU. COUNCILMEMBERS, ANY DISCUSSION? ALL RIGHT. WITH THAT, DO COUNCIL MEMBERS THAT CONQUER WITH US PURSUING THIS CONCEPT? I NEED A HAND. OKAY. THOSE THAT DON'T. HI, DICK. I SEE YOU. THANK YOU. TERRIFIC. THANK YOU LOU. NEXT DR. RAY CO TOY AM AH. -- TO UNDERSTAND STRUCTURAL BIRTH DEFECTS. >> PROGRAM SEEKS COUNCIL TO ISSUE INITIATIVE TITLED SMALL RESEARCH [INDISCERNIBLE] FOR ESTABLISHING BASIC SCIENCE CLINICAL COLLABORATIONS TO UNDERSTAND BIRTH DEFECTS. BIRTH DEFECTS OCCUR IN 1 IN EVERY 33 INFANTS BORN IN THE UNITED STATES EACH YEAR. DESPITE DEVASTATING IMPACT ON BIRTH DEFECT ON EFFECTIVE CHILDREN AND FAMILY WE STILL UNDERSTAND LITTLE OF IT. THIS INITIATIVE AND TO SUPPORT COLLABORATIVE EFFORTS BETWEEN BASIC RESEARCHERS STUDYING DEVELOPMENTAL BIOLOGY AND SCIENTISTS WORKING WITH PATIENTS TO OBTAIN PRELIMINARY DATA FOR FUTURE SEARCH GRANT APPLICATIONS SUCH AS RO1. THIS IS AN ISSUE REQUEST. SOME KIND GRANTEES FUNDED UNDER THIS INITIATIVE ARE PLANNING R01 SUBMISSION TO CONTINUE RESEARCH PROGRAMS THROUGH ESTABLISHED KWLABRATION. WE ARE PLANNING TO CONTINUE THE EFFORT AND BETTER UNDERSTANDING OF THE BIOLOGY AND GENETICS BASIC OF STRUCTURE BIRTH DEFECTS THUS RESULTING IN BETTER THERAPEUTICS AND PREVENTION. >> DELLA HANN: THANK YOU. DISCUSSION FROM MEMBERS OF COUNCIL? OKAY. THOSE THAT CONQUER? THOSE THAT DO NOT? TERRIFIC. THANK YOU RAYCO. NEXT DR. TOOUB AH FAIR WILL PRESENT ON NATURAL HISTORY OF DISORDERS SCREENABLE IN A NEWBORN PERIOD. >> PROGRAM SEEKS COUNCIL APPROVAL FOR INITIATIVE TITLE -- SCREENABLE IN NEWBORN PERIOD STATE NEWBORNING SCREEN PROGRAMS HERITABLE DISORDERS PART OF THE RECOMMENDED UNIFORM SCREENING PANEL KNOWN AS ROSS WHICH REQUIRES EVIDENCE-BASED REVIEW PROCESS EVALUATING NATURAL HISTORY OF THE DISORDER -- IT IS DIFFICULT TO GET FUNDING FOR NATIONAL HISTORY STUDIES THEY ARE NOT OFTEN HYPOTHESIS DRIVEN RARE DISEASES THAT COULD BE ADDED TO IT THESE DISEASES COULD BENEFIT FROM NATURAL HISTORIES FOR GOAL OF THE REVIEW. GOAL IS TO DO UNDERSTANDING -- CURRENTLY ARE AND [INDISCERNIBLE] DEFINING ONSET SEQUENCE AND TIMING OF SYMPTOMS TO DEVELOP AGE APPROPRIATE AND DISEASE STAGE TREATMENTS RELEVANT FOR NEWBORN SCREENING ALIGNS WITH NCC MANDATE AS PART OF HUNTER KELLY NEWBORN RESEARCH SCREENING PROGRAM AND RESEARCH AND THEIR TRANSLATION INTO CLINICAL CARE. >> DELLA HANN: THANK YOU TOOUBA. ANY DISCUSSION ON THIS CONCEPT? OKAY. THOSE THAT CONCUR? >> I HAVE A QUICK COMMENT. WORKING WITH COLLABORATION WITH STATE GOVERNMENTS AND SCREENING PROGRAMS? >> THIS WOULD -- NO. >> AUDIENCE: [LAUGHING]. >> DELLA HANN: DO YOU WANT TO EXPLAIN WHAT IT IS IF THEY EVER ARE INVOLVED? TURN YOUR MIC ON FOR ME, PLEASE. >> IS IT ON? P OKAY. WE DO WORK WITH STATE PROGRAMS AND OUR CONTRACTORS AND BSA NEWBORN RESEARCH NETWORK TO COORDINATE THE STUDIES HOWEVER THE PARTICULAR INITIATIVE IS FOR RESEARCH PROJECTS ONLY. SO THE INVESTIGATORS MAY CHOOSE TO WORK WITH STATE PROGRAMS BUT IT IS NOT REQUIRED AS PART OF THE INITIATIVE. >> DELLA HANN: THANK YOU. >> OKAY. THAT MAKES SENSE. >> DELLA HANN: ANY ADDITIONAL DISCUSSION? OKAY. THOSE THAT CONCUR? THOSE THAT DON'T? THANK YOU. NEXT WE HAVE DR. JAMES COULOMBE WHO WILL PRESENT ON TWO CONCEPTS FIRST IS SMALL RESEARCH ANALYSIS AND PEDIATRIC RESEARCH DATA. >> PER INITIATIVE ENTITLED SMALL RESEARCH GRANTS PER ANALYSIS OF GABRIELA MILLER FIRST PEDIATRIC RESEARCH DATA IN RESPONSE TO CONGRESSIONAL ACT NIH COMMON FUND ESTABLISHED THE GABRIELLA MILLER PEDIATRIC RESEARCH PROGRAM USING FUNDS APPROPRIATED FOR KIDS FIRST PROGRAM IS PROVIDING SEQUENCING SERVICES AND DATA RESOURCE CENTER -- FROM CHILDHOOD CANCER AND BIRTH DEFECTS COHORTS AND PROVIDE A CENTRAL PORTAL WHERE DATA AND ANALYSIS TOOLS ARE AVAILABLE TO THE RESEARCH COMMUNITY. INVESTIGATORS THAT RECEIVE SEQUENCING SERVICES FROM KIDS FIRST ARE NOT PROVIDED WITH SUBSTANTIAL ANALYSIS SUPPORT BECAUSE OF RELATIVELY LIMITED FUNDS AVAILABLE THROUGH KIDS FIRST PROGRAM. CONCEPT APPROVAL THAT WE ARE SEEKING IS FOR NICHD WITH EXPECTED PARTICIPATION OF IC THES THAT PARTICIPATE IN KID'S FIRST WORKING GROUP TO SUPPORT ANALYSIS AND ANNOTATION OF KIDS FIRST DATA SETS OR DEVELOPMENT OF ANALYSIS TOOLS AND METHODOLOGIES TOWARDS IDENTIFICATION OF GENOMIC VARIANCE CONTRIBUTING TO CHILDHOOD CANCERS OR STRUCTURAL BIRTH DEFECTS. >> THANK YOU, JAMES. ANY COUNCIL DISCUSSION? >> [INDISCERNIBLE] AGAIN. I THINK I'M GLAD WE ARE NOT JUST FUNDING CREATION OF LOTS OF THE REFERENCE DATA SETS AND FUNDING FOLKS TO USE THEM LIKE THIS EFFORT. I'M IN FAVOR OF THIS. >> DELLA HANN: GOOD. ANY ADDITIONAL DISCUSSION? OKAY. THOSE THAT CONCUR? ALL RIGHT. GREAT. THANK YOU. THOSE THAT DON'T? ALL RIGHT. THANK YOU. NOW, FOR THE SECOND ONE FOR JAMES, CONCEPT ON NICHD BIOMEDICAL INFORM ATTIC [INDISCERNIBLE]. YOUR MICROPHONE IS OFF. >> HOW DID THAT HAPPEN? >> DELLA HANN: WHO KNOWS. >> PROGRAM REQUEST COUNCIL APPROVAL FOR INITIATIVE TO SUPPORT INFORMATICS RESOURCES FOR BIOMEDICAL COMMUNITY. NEED FOR THESE RESOURCES THAT ARE ESSENTIAL INFORMATION RESOURCES FOR EXPERIMENTAL DESIGN AND SERVE FOR INFORMATION HUBS CURATING AND MAKING AVAILABLE GENOME SEQUENCE AND RESEARCH STUDY RESULTS TO THE BIOMEDICAL RESEARCH COMMUNITY. BIOINFORMATICS RESOURCES ARE IMPORTANT TO THE BIRTH DEFECTS AND DEVELOPMENTAL BIOLOGY COMMUNITIES AS THEY PROVIDE ESSENTIAL SHAL RESOURCES FOR DESIGNING AND INTERPRETING FUNCTIONAL STUDIES VARIANCE IDENTIFIED BY SEQUENCING OF HUMAN PATIENT POPULATIONS THIS INITIATIVE IS TO PROVIDE SUPPORT FOR CONTINUED AVAILABILITY OPERATION AND IMPROVEMENT AND DISEM NATION OF DATABASES AND DIGITAL INFORMATION AND SOFTWARE TOOLS THAT ARE OF SPECIAL IMPORTANCE AND DEMONSTRABLE VALUE OF SERVING NEEDS OF NIH BIOMEDICAL RESEARCH COMMUNITY. >> THANK YOU, JAMES. ANY COUNCIL DISCUSSION? >> THIS ONE AS WELL. NO SURPRISE. ENCOURAGE AS MUCH OF THE DATA AND TOOLS TO BE MADE OPEN SOURCE AS MUCH AS POSSIBLE FROM NIH PERSPECTIVE. >> DELLA HANN: OKAY. THANK YOU. ANY ADDITIONAL DISCUSSION? THOSE THAT CONCUR? THOSE THAT DON'T? OKAY. THANK YOU. THANK YOU, JAMES. NEXT IS ARCHIVING AND DOCUMENTING CHILD HEALTH HUMAN SERVICES AND DEVELOPMENT DATA SETS. >> GOOD MORNING. ARCHIVING AND DOCUMENTING CHILD HEALTH IN HUMAN AND DEVELOPMENTAL DATA SETS PUBLICLY AVAILABLE AND IMPROVE QUALITY OF ASSOCIATED DOCUMENTATION AND REMAINS IN NEED TO STIMULATE ARCHIVING AND DOCUMENTATION OF FUNDED DATA RESOURCES NOT ALL AWARDS ARE COVERED BY NIH DATA SHARING POLICY THAT APPLIES TO LARGE GRANTS AND SOME RFAS INCREASING DATA SHARES PRIORITY AND EXTRAMURAL BRANCHES AND THIS INITIATIVE PRIORITIZE DATA SETS WITHIN SCIENTIFIC MISSION OF INSTITUTE GIVING HIGHEST PRIORITY TO DATA COLLECTED BY -- ANNOUNCEMENT WE WILL CONTINUE TO INVITE APPLICATIONS THAT SUPPORT ARCHIVING AND DOCUMENTATION AND INCREASE AVAILABLE OF NICHD FUNDED DATA BY ANALYSIS OF THE SCIENTIFIC COMMUNITY. THANK YOU. >> DELLA HANN: THANK YOU, REJ EVEN AH. DISCUSSION FROM COUNCIL. >> YES. I DIDN'T COME UP WITH THE LIST, BUT I CLEARLY LOVE ALL OF THEM. >> AUDIENCE: [LAUGHING]. >> YOU COULDN'T HAVE MADE THE LIST FOR ME. I LOVE THIS ONE A LOT. IN ONE SENTENCE, LOTS OF PEOPLE ARE FORCED ONE WAY OR ANOTHER TO CONTRIBUTING TO DASH. THIS COVERS A BUNCH OF PEOPLE THAT WANT TO CONTRIBUTE BUT MIGHT NOT HAVE FUNDING TO DO IT BUT HAVE GREAT DATA SETS I SENT IT TO NAID ASKING THEM WHY DON'T WE HAVE ONE THERE SO CLEARLY I'M IN FAVOR OF THIS ONE. SPAEK THANKS ATOOL. ANY OTHER DISCUSSION? GO AHEAD. >> THANK YOU. I ASKED MY COUNCIL BUDDY EARLIER WAS WHETHER OR NOT WE COULD SEE THIS OPPORTUNITY OPEN TO INTERNATIONAL DATA SETS FUNDED BY NIC-HCD CURIOUS AS TO WHETHER THAT HAS BEEN A CONSIDERATION IN YOUR PLANNING. THANK YOU. >> CERTAINLY THIS RO3 OPPORTUNITY IS OPEN TO ALL COLLECTED DATA. USUALLY PI COMES IN WITH APPLICATION THEY HAVE ACCESS TO DATA AND ARE ABLE TO IDENTIFY IT. IF WE FUNDED THEM BEFORE WE COULD CERTAINLY -- IT WOULD SUPPORT THEM AGAIN. THANK YOU. ANY ADDITIONAL DISCUSSION? ALL RIGHT. THOSE THAT CONCUR? THOSE THAT DON'T? THANK YOU. THANK YOU REGINA. NEXT IS DR. LAYLA ESPOZ EATO. ANIMAL HUMAN INTERACTION RESEARCH. >> PROGRAM SEEKS COUNCIL FOR -- HUMAN INTERACTION HAI RESEARCH 75% OF US HOUSEHOLDS HAVE PETS SIZE OF FAMILIES ARE DECREASING. -- MOST OF THE STUDIES FOCUSING ON HOW ANIMALS EFFECT CHILDREN'S HEALTH DEVELOPMENT WELL -- KEY DEVELOPMENTAL QUESTIONS AND ESTABLISHING CAUSAL RELATIONSHIPS THERE IS A NEED FOR MORE RESEARCH ON ANIMAL ASSISTED INTERVENTIONS AND HIGHLIGHT AREAS RIGHT FOR INVESTIGATION REGARDING HAI AND HOW IT RELATES TO CHILD DEVELOPMENT HEALTH AND THERAPEUTIC INCLUSION OF ANIMALS FOR THOSE WITH DISABILITIES REQUIRING REHABILITATIVE SERVICES THEY ENGAGE -- DIVISION OF MARS INCORPORATED WHICH HAS A SHARED INTEREST IN THIS RESEARCH. [INDISCERNIBLE] WAS NOT INVOLVED IN DEVELOPING OF THIS CONCEPT NOR IN ANY DECISION PAST OR FUTURE REGARDING FUNDING FOR THIS AREA OF NHAID SUPPORT. >> DELLA HANN: THANK YOU, LEILA. >> I WAS ABLE TO SEE THE RECENT EVENING NEWS CLIP THAT WENT ON TWITTER RELATED TO THE USE OF ANIMAL SUPPORTING VETERAN REHAPPENILITATION NOTING IT WAS FUNDED THROUGH THIS. GREAT AND INTO THE PUBLIC BETTER UNDERSTANDING WHAT NAID DOES. INTERESTED IN PUBLIC PARTNERSHIP OF MARS AND IRRESPECTIVE APPROVING CONCEPT I'M HAPPY TO DO TODAY. MIGHT BE INTERESTING FOR US NOT NECESSARILY IN MEETING PER-SE BUT PERHAPS IN E-MAIL TO FIND OUT MORE ABOUT THE COLLABORATION WITH MARS AND WHETHER THEIR EFFORTS AT NACID TO BUILD PARTNERSHIPS LIKE YOU HAVE THANK YOU. >> DELLA HANN: THAT COULD BE POSSIBLE WE CAN HAVE IT AT AN OPEN MEETING TO DISCUSS IT AS WELL. IT WOULD BE FINE. I'M SURE LAL AH AND GYM AND OTHERS WOULD BE HAPPY TO TALK ABOUT THE PARTNERSHIP. OTHER ADDITIONAL DISCUSSION? >> HELLO. >> DELLA HANN: HI. >> HI. GOOD MORNING FROM DENVER. I'M NOT ATOOL. >> AUDIENCE: [LAUGHING]. >> I THINK THERE IS AN OPPORTUNITY WITH THIS PARTICULAR CONCEPT. I HOPE PEOPLE WILL THINK ABOUT THAT IS NOT JUST ASSISTANCE RELATIONSHIP BETWEEN ANIMALS AND HUMANS BUT ABUSIVE ONE THERE IS OVERLAP ANIMAL AND CHILD ABUSE. THIS MIGHT BE THE ONLY CONCEPT I HAVE SEEN IN MONTHS THAT HAVE OPPORTUNITY TO BUBBLE UP WORK IN CHILD MALTREATMENT AREA. THE. >> THAT IS SOMETHING WITHIN THE SCOPE OF THE REQUEST AND FUNDING OPPORTUNITY ANNOUNCEMENT. WE HAVE FUNDED WORK THROUGH THIS PROGRAM ANOUNGSMENT ON OVERLAP BETWEEN CHILD ABUSE AND ANIMAL ABUSE IN THE PAST. >> OKAY. ANYWAY, I'M FOR IT. >> THANK YOU. ANY ADDITIONAL DISCUSSION? THOSE THAT CONCUR? THOSE THAT DON'T? EXCELLENT. THANK YOU, LAYLA. NOW, FINAL. DR. DEN EAT AH K. WILL PRESENT ON GENOMIC CURATION PANELS. >> THANK YOU. GOOD MORNING. PROGRAM SEEKS COUNCIL APPROVAL FOR AN INITIATIVE ENTITLED GENOMIC EXPERT CURATION PANELS. GENOMIC TESTINGIS INCREASING WILL I ROUTINE IN CLINICAL PRACTICE RESULTING IN LARGE NUMBERS OF VARIANCE IN UNKNOWN SIGNIFICANCE AND CLINICAL NEED TO DETERMINE CLINICAL RELEVANCE OF THE VARIANCE. NIH RECENTLY ESTABLISHED CLEN GENERAL AND OPEN ACCESSIBLE CLINICAL GENOME INFRASTRUCTURE THAT CAPTURES INFORMATION ABOUT GENOMIC VARIANCE AND RELATED CLINICAL INFORMATION. CLIN GENERAL PROVIDES TOOLS TO SUPPORT GENE AND VARIANT CURATION AND DOESN'T HAVE RESOURCES TO SUPPORT EXPERT PANELS OF SCIENTISTS TO CURATE VARIANCE FOR WIDE RANGE OF DISORDERS SUPPORTED BY NICH. TO ADDRESS THIS NEED THEY ARE ISSUING INITIATIVE TO SUPPORT GENE DISEASE SPECIFIC EXPERT CURATION PANELS TO IDENTIFY GENOMIC HIGH -- ICS THAT ARE PAFRPTING WILL BE PARTICIPATING IN THIS INITIATIVE THAT WILL LEVERAGE THE RESOURCES DEVELOPED BY CLINGEN. >> DELLA HANN: THANK YOU DEN YOU'DA. DISCUSSION FROM COUNCIL. >> YEAH. MY FINAL COMMENTS BEFORE LUNCH I SUPPOSE TO SET THE CONTEXT. CLEN GENERAL CAME AROUND BECAUSE TOO MANY GENERALO SEQUENCING COMPANIES HAD PROPRIETARY DATABASES WHAT THEY MEANT FOR HUMAN HEALTH AND DISEASE THESE ARE IMPORTANT EFFORTS SPENDING MULTIPLE INSTITUTES I'M GLAD TO SEE EXPERT PANELS COULD BE FUNDED IN THIS. I DIDN'T KNOW THIS WAS GOING TO START HAPPENING. THEY ARE OPEN DATABASES FOR COMPANIES AND ACADEMICS AND CERTAINLY MOSTLY FOR PATIENTS. I'M A BIG FAN OF THIS. >> DELLA HANN: THANK YOU. >> QUICK QUESTION IS THIS SOMETHING OTHER INSTITUTES COULD ALSO PARTNER WITH? THERE IS CERTAINLY OVERLAP IN ANY OF THE GENOMIC DATABASES. >> YES. WE DISCUSSED THIS INITIATIVE WITH A NUMBER OF ICS WE HAVE A NUMBER OF ICS THAT WANT TO PARTNER WITH THIS WE WANT TO TRANSIT INTO COMPLETELY NIH BUT WE ARE WORKING ON IT. >> YES. THIS FIELD NEEDS THAT KIND OF INPUT FROM EXPERT PANELS A GENE IS A GENE AND VARIANT IS A VARIANT. PEOPLE KNOW THEIR GENES WELL WE NEED THESE INITIATIVES TO HELP US ALL ESPECIALLY IN NEWBORN WHERE ASYMPTOMATIC TO INTERPRET GENOMIC DATA. >> I WOULD ALSO ADD FETAL LIFE OR IN EARLY LOSS THAT THERE IS PROBABLY A LOT OF MUTATION THERE THAT WE DON'T KNOW ABOUT BECAUSE THOSE PRODUCTS OF CONCEPTION ARE NOT GENOTYPED OR PEOPLE ARE NOT RECOGNIZING THE CONTRIBUTION OF GENETIC CONDITIONS TO REPRODUCTIVE HEALTH AS WE HAVE BEEN DISCUSSING THIS MORNING. >> TYPICALLY IF ANYTHING IS DONE ON POCS THEY ARE DONE ON KARYOTYPE OR ARRAY TYPE BUT NOT ON [INDISCERNIBLE] THAT WOULD BE AREA THAT IT WOULD EXPAND I THINK IN BABIES,AE. SPAEK NO DISCUSSION. THOSE THAT CONCUR? THOSE THAT DON'T? >> YAI. >> ALL RIGHT. GREAT. THANK YOU, NEIL. I WILL TURN IT BACK TO DR. BEON KI. >> THANK YOU DELLA IT IS TIME FOR LUNCH FOOD MAP FOR EATING PLACES. ARE THERE FOOD TRUCKS ON TUESDAYS? JUST THURSDAYS I THINK UNFORTUNATELY. YOU ARE LIMITED TO AVAILABLE PERMANENT OPTIONS HERE. COUNCIL BUDDY IS AVAILABLE TO HELP YOU SHOULD YOU REQUIRE ASSISTANCE. WE WILL RECONVENE PROMPTLY AT 1 O'CLOCK FOR AFTERNOON CLOSED SESSION.